The Commercialization of Stem Cells ANNA CAULDWELL, PHD ANALYST, CNS, AUTOIMMUNE/INFLAMMATION & OPHTHALMOLOGY
|
|
- Alvin Miles
- 8 years ago
- Views:
Transcription
1 The Commercialization of Stem Cells ANNA CAULDWELL, PHD ANALYST, CNS, AUTOIMMUNE/INFLAMMATION & OPHTHALMOLOGY
2
3 Recent advances have shown that stem cells can provide truly restorative and diseasemodifying treatment. Stem cells have been used to successfully restore sight to those with vision loss and products are in development for some of the most important and intractable chronic conditions. These treatments offer greater potential over palliative ones and so expectations riding on these therapies are high. Here, we investigate the involvement of biotech and pharma companies in this high-reward, but also high-risk industry. Historical trends Citeline s Pharmaprojects tracks industry-sponsored drug development for human disease since 1980 and since 1995 we have additionally been snapshotting key data points each year. Figure 1 profiles a year-on-year comparison of the number of stem cell therapies by phase of development. Perhaps unsurprisingly, the overall trend is of a considerable increase in the number of stem cell therapies in every phase of development over time. Stem cell therapies started to be developed in the late 1990 s; however, it wasn t until the early 000 s following the discovery of human embryonic stem cells that this area really started to take off, driven by high expectations about their therapeutic potential. There was an upsurge in commercial interest and several specialist cell therapy companies were launched whose focus was on the translation of research into commercially successful products. Recently, there has been a considerable expansion of late stage candidates there are currently 87 products in Phase II, Phase III or Pre-registration, while in 010 there were only 18. The space is clearly maturing with talk of pivotal trials becoming commonplace. Figure 1. Trends in Stem Cell Therapy Development Over Time No. of therapies Launched Registered Pre-registration Phase III Phase II Phase I Preclinical Source: Citeline s Pharmaprojects, May 015 3
4 Figure focuses on the number of drugs currently in each stage of development. This healthy developmental pipeline has a particularly busy Phase II section with 73 drugs it is common to see a build-up in this phase because drugs spend far more time passing through Phase II, than undergoing the much shorter Phase I trials and so this effect is partly produced by the snapshot nature of the data. Eight stem cell therapies have now been launched in at least one country in the world (mainly in Australia and South Korea). These products have been developed to treat osteoarthritis, myocardial infarction, anal fistula, bone regeneration and the treatment of torn or damaged tendons, ligaments and cartilage. These successes suggest opportunities for similar clinical candidates to progress. Figure. Number of Therapies by Phase Preclinical Phase I Clinical Trial Phase II Clinical Trial Phase III Clinical Trial Pre-registration Registered Launched Source: Citeline s Pharmaprojects, June 015 Where is the development taking place? Citeline s Sitetrove was used to investigate where in the world this commercial stem cell therapy research is being undertaken (Figure 3). A large number of trials sites are located in the US and the EU, but a number of regional regulations have also had a considerable impact on where products are being developed. Japan is fast becoming a center of importance thanks to regulatory changes which were introduced at the end of 014. Japan formally enacted new legislation governing the development, approval and use of regenerative medicines. The new laws provide a legal framework designed to encourage the development of novel regenerative therapies and to speed up product approvals in the sector. This new approval process is similar to the one used in South Korea. Conditional approvals can now be granted based on safety and efficacy data from Phase II clinical trials instead of full Phase III programs. These conditional approvals will allow for commercial sales for up to seven years. (Source: PharmAsia Japan: Sumitomo Dainippon Pharma is one of the Japanese companies investing in this field. It has a joint venture with Healios KK to commercialize induced pluripotent cell treatments for macular degeneration. Earlier this year the U.S.-based Athersys entered into a cell therapy alliance with Chugai (Roche). Chugai will develop and commercialize Athersys MultiStem for ischemic stroke in Japan. The alliance is worth $10 million 4
5 upfront to Athersys plus additional development and regulatory milestone payments of up to $45 million. Moreover, as recently as April this year Takeda announced that it will work with the Center for ips Cell Research Application (CiRA) of Kyoto University on stem cell research in a 10 year program to develop clinical applications of induced pluripotent stem cells in areas such as heart failure, diabetes mellitus, neurological disorders and cancer immunotherapy. Whilst this new regulation enables stem cell therapies to reach the market more quickly, some critics are concerned about the lack of rigorous testing and argue that stem cell therapies which aren t assessed in Phase III trials should only be designated experimental treatments. Figure 3. Industry-Sponsored Trial Site Locations Source: Citeline s Sitetrove, June 015 Which are the most commercially attractive therapeutic areas to invest in? In order to determine which disease areas are attracting the most R&D investment, we grouped the indications in Pharmaprojects, as shown in Figure 4. Cardiovascular is the hottest area for stem cell research, accounting for more than a quarter of all stem cell therapies currently in development. The Phase III pipeline is dominated by therapies for heart failure, angina and myocardial infarction, making it the most advanced pipeline among all other therapy areas (Table 1). Currently, conventional management for heart failure does not address loss or scarring of cardiac muscle cell mass, resulting in a high level of unmet medical need and an opportunity for regenerative stem cell therapies. A mix of speciality and large pharma are trying to capitalise in the cardiovascular space, including Bioheart, Teva and Baxter International. Baxter is currently 5
6 running a pivotal Phase III trial to evaluate the efficacy and safety of adult autologous CD34+ stem cells to increase exercise capacity and amelioration of anginal symptoms in patients with chronic myocardial ischemia, one of the most severe forms of coronary artery disease. The study has enrolled approximately 300 patients in over 40 clinical sites in the US (Trialtrove: TrialtroveID pdf). A large number of stem cell products are also in development in the metabolic and neurological therapeutic areas. Some of the key indications under investigation include hepatic dysfunction, bone regeneration, spinal cord injury and Parkinson s disease. Ophthalmology is another up and coming area for stem cell therapies with treatments for corneal injury, macular degeneration, optic neuritis, macular oedema and diabetic retinopathy in the clinic. In December last year the EMA approved Holoclar, a treatment for moderate to severe limbal stem cell deficiency due to physical or chemical burns to the eye(s) in adults. This was the first advanced therapy medicinal product containing stem cells to be approved in the EU. When considering the most commercially attractive cell type to invest in, mesenchymal stem cells (MSCs) are currently ahead of the field. The ethical concerns and potential for teratoma formation with embryonic stem cells, and induced pluripotent stem cells, have compromised their utility; whereas, the unique properties of MSCs have led to their intense investigation as a cell-based therapeutic strategy. The advantages of MSCs are that they are easily isolated, can be amplified from the bone marrow, are immunologically tolerated as an allogeneic transplant, and have multi-lineage potential. Figure 4. Number of Stem Cell Products by Therapeutic Area Phase III Phase II Phase I Preclinical No. of therapies Autoimmune/ Inflammation 8 7 Cardiovascular 5 Dermatological Gastrointestinal Genitourinary Infectious Disease Metabolic Neurological Oncology Ophthalmology Respiratory Source: Citeline s Pharmaprojects, May 015 6
7 Table 1. Stem Cell Therapies in Phase III Development or Pre-Registration THERAPY DESCRIPTION ORIGIN INDICATION COMPANY MyoCell myoblasts removed from a patient s thigh muscle, isolated, grown through their proprietary cell culturing process, and injected directly in the scar tissue of a patient s myocardium autologous heart failure Bioheart carlecortemcel-l/ StemEX ex vivo expanded umbilical cord blood cell graft allogeneic haematopoietic reconstruction after chemotherapy in haematological malignancies Gamida Cell; Teva stem cell therapy, Baxter blood-derived selected CD34+ stem cell therapy autologous angina Baxter International CX-601 suspension of allogeneic expanded adipose-derived stem cells allogeneic anal fistula TiGenix CEP-41750/Revascor adult-derived mesenchymal precursor cells allogeneic heart failure Mesoblast; Teva PHASE III C-Cure mesenchymal bone marrow-derived stem cells, Stemedica-1 bone marrow-derived stem cells differentiated into cardiopoietic cells ischemic tolerant mesenchymal stem cells autologous heart failure Celyad allogeneic myocardial infarction Stemedica mesenchymal precursor cells, allogenic, BMT, Mesoblast adult-derived mesenchymal precursor cells allogeneic stem cell engraftment; unspecified haematological cancer Mesoblast; Teva PREOB osteoblastic cells derived from bone marrow mesenchymal stem cells autologous osteonecrosis; fracture healing Bone Therapeutics Cerecellgram-Spine Cerecellgram-Stroke bone marrow derived mesenchymal stem cells bone marrow derived mesenchymal stem cells autologous spinal cord injury Pharmicell autologous cerebral ischaemia Pharmicell rexlemestrocel-l, Mesoblast proprietary adult-derived mesenchymal precursor cells allogeneic chronic lower back pain due to moderate intervertebral disc degeneration of the lumbar spine Mesoblast Stempeucel ex vivo cultured adult bone marrow-derived mesenchymal stem cells allogeneic limb ischaemia; osteoarthritis Stempeutics; Cipla PRE-REG GSK CD34+ haematopoietic stem/ progenitor cells engineered ex vivo with a retroviral vector encoding the therapeutic gene adenosine deaminase autologous severe combined immunodeficiency GlaxoSmith- Kline Source: Citeline s Pharmaprojects, May 015 7
8 Which companies are investing in the industry? So who are the key players in this field? We ve pulled out the companies with four or more products in development and it s apparent that most of these are cell therapy specialists (Figure 5). Teva bucks the trend by being the only top 0 pharmaceutical company on the list. Biotime is the biggest player in the stem cell field with 9 products in development. Through their subsidiary companies Cell Cure Neurosciences and OrthoCyte, they are developing OpRegen, (a cellbased therapy for age-related macular degeneration), and therapies for arthritis. In addition, their subsidiary ReCyte Therapeutics is using proprietary technology to reverse the developmental aging of human cells to manufacture young vascular progenitors for the treatment of age-related vascular disease. Australian company Mesoblast is another key player with 8 stem cell therapies in development. Mesoblast s allogeneic regenerative medicine products focus on repair of damaged tissues and modulation of inflammatory responses in conditions with significant unmet medical needs. The company s clinical product candidates focus on four major areas: orthopedic diseases, cardiovascular diseases, systemic diseases and improving outcomes of bone marrow transplantation in patients with cancer or genetic diseases. Mesoblast s remestemcel-l was acquired from Osiris Therapeutics as an off-the-shelf adult mesenchymal stromal cell product, which has been approved in several countries for acute graftversus-host disease, and it is expected to be launched in Japan later this year. Mesoblast had a further boost recently with Celgene confirming that it will invest $45 million in the company. Figure 5. Companies With Active Stem Cell Therapy Pipelines Number of Therapies BioTime Cell Therapy Pharma Biotechnology Phase III Phase III Phase III Phase II Phase II Preclinical Phase I Preclinical Preclinical Mesoblast Pluristem Teva Stemedica Bharat Serums and Vaccines Bone Therapeutics CHA Bio & Diostech Ocata Therapeutics Pharmicell Xcelthera Source: Citeline s Pharmaprojects, May 015 8
9 The pharmaceutical industry has embraced stem cells as a tool in drug discovery. Most of the major pharmaceutical companies are using embryonic stem cells or adult stem cells for internal drug discovery programs. These internal efforts are often enhanced through the expertise of external partnerships with academics or biotech companies. However, big pharma has historically been slow to invest in developing stem cell-based regenerative medicine. The barriers facing this industry will be dependent on the type of cell-based approach under development, but there are also a range of more general concerns that have worried investors. These include a lack of familiarity with the business model, pricing, concerns over whether the products can be manufactured on a commercial scale, regulatory concerns and the question of whether they can be proven safe and offer substantial benefit over existing therapies. Despite the concerns these truly restorative and disease-modifying treatments offer considerable promise and the involvement of big pharma has the potential to dramatically support the space in terms of providing finance, the capability of conducting Phase II/III clinical trials, expertise in communicating with regulators and lobbying for regulation in their favour, as well as the potential to mass produce and enable worldwide distribution of cell therapies. Table shows the stem cell products being developed by the top pharma companies. There s been a steady increase in the number of therapeutic products in development year-on-year since the late 000 s with many well-recognised names joining the fray. For several companies the tipping point has been reached and the potential benefits are starting to outweigh the risks. Indeed, not only has there been an increased number of pharmaceutical stem cell assets; but also the opening of large separate units and programs (e.g. Neusentis of Pfizer) and a trend for more partnership with academic institutions, which illustrates the growth in this sector. It seems that big pharma has moved from being curious about the stem cell therapy industry to being increasingly committed. In contrast to the key players shown in Figure 5, who were mostly developing their own products, the big pharma companies are more likely to be in-licensing products for development. These companies often take the observer s chair as a company works to complete a crucial leg of the R&D journey. Teva has the most products in active development with 7 in total. The company has licensee agreements in place with Mesoblast, BioTime and Gamida Cell. In addition, Teva has three products in Phase III development including Revascor which is currently in a global, pivotal, 1,700-person trial in congestive heart failure (Trialtrove: Novartis broadened its position in the stem cell space in 014 by investing $35 million in Gamida Cell. This development came after Novartis announced in September 013 that it had partnered with Regenerex to gain access to their stem cell technology. Johnson & Johnson is another big name which has recently shown its commitment to this field by betting $1.5 million on the Capricor Therapeutics cell therapy program for cardiovascular applications, notably CAP-100, through its subsidiary, Janssen Pharmaceuticals, Inc. In addition, through Janssen Pharmaceuticals, J&J invested in ViaCyte s VC-01 combination product being developed for type 1 diabetes. The agreement provides Janssen with an option in the future to consider a transaction related to the VC-01 combination product. Despite these investments, there is also an increasing realization of just how long a road stem cell research has to travel and this has triggered some companies to back out of the area. For instance, Osiris offloaded its mesenchymal stem cell platform and Prochymal to Mesoblast, after Sanofi decided not to sign up to a $1.5 billion collaboration that came with a $130 million upfront payment. Even so, other companies are showing that they are still prepared to invest Chiesi and AstraZeneca entered the space just this year with their own preclinical candidates. 9
10 Table. Stem Cell Therapies Being Developed by Big Pharma THERAPY DESCRIPTION COMPANY PRECLINICAL anticancers, MedImmune epidermolysis bullosa therapy, Chiesi HLS-001 PF anti-cancer stem cell therapies to directly and specifically attack tumor cells ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector for epidermolysis bullosa ips cell-derived retinal pigment epithelial cells for age-related macular degene embryonic stem cell derived retinal pigment epithelium for wet age-related macular degeneration AstraZeneca (Originator) Chiesi (Originator) Dainippon Sumitomo Pharma (Licensee) Pfizer (Originator) Multistem multipotent adherent progenitor cells for ischemic stroke Roche (Licensee) Parkinson s therapy, Cell Cure NeurArrest embryonic stem cell-derived mid-brain progenitor cell therapy embryonic stem cell-derived neural progenitor cell therapy for multiple sclerosis Cenplacel-L placental-derived adherent stem cell product for Crohn s disease Celgene (Originator) SB-63 allogeneic neural stem cell therapy for cerebral ischaemia Dainippon Sumitomo Pharma (Licensee) GSK ex vivo gene therapy based on insertion of a lentiviral vector expressing human Wiskott-Aldrich syndrome protein into autologous CD34 positive haematopoietic stem cells GlaxoSmithKline (Originator) PHASE II GSK CAP-100 ex vivo gene therapy based on insertion of a lentiviral vector expressing arylsulfatase A (ARSA) into autologous CD34 positive haematopoietic stem cells for metachromatic leukodystrophy allogeneic cardiosphere-derived stem cells for heart failure and myocardial infarction GlaxoSmithKline (Originator) Johnson & Johnson (Licensee) HSC-835 LFU835-expanded umbilical cord blood haematopoietic stem cells for leukaemia & lymphoma Novartis (Originator) Multistem multipotent adherent progenitor cells for irritable bowel disease and ulcerative colitis Pfizer (Licensee) MPC-5-IC allogeneic stem cell therapy based upon proprietary adult-derived mesenchymal precursor cells for intra-coronary treatment of acute myocardial infarction PDA-00 placental derived stem cells for peripheral arterial disease & diabetic foot ulcers Celgene (Originator) Stem cell therapy, Baxter blood-derived selected CD34+ st em cell therapy for angina Baxter International (Originator) Revascor allogeneic stem cell therapy based upon its proprietary adult-derived mesenchymal precursor cells for heart failure & myocardial infarction MPC-CBE allogeneic stem cell therapy based upon its proprietary adult-derived mesenchymal precursor cells for bone marrow transplantation PHASE III Carlecortemcel-l cord blood-derived ex vivo expanded CD34-positive stem/progenitor cells for haematopoietic reconstruction after chemotherapy in haematological malignancies VC-01 pancreatic endocrine ß-islet cells derived from embryonic stem cells for type I and II diabetes Pfizer (Licensee) OpRegen retinal pigmented epithelial cells derived from human embryonic stem cells for dry age-related macular degeneration CNTO-476 allogeneic umbilical cord tissue-derived cell therapy Johnson & Johnson (Originator) PRE-REG GSK Stempeucel autologous stem cell therapy that consists of CD34+ haematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the therapeutic gene adenosine deaminase for ADA severe combined immune deficiency ex vivo cultured adult bone marrow-derived mesenchymal stem cell product for osteoarthritis & critical limb ischemia, other indications GlaxoSmithKline (Originator) Cipla (Licensee) Source: Citeline s Pharmaprojects, May
11 Conclusions The worldwide stem cell therapy market and development pipelines are poised to grow at a considerable rate. Increased global awareness, as well as funding and commitment from larger pharmaceutical companies, are propelling the growth of this industry. Allogeneic stem cell therapies enable the treatment of many patients from the same cell bank in an off-the-shelf manner and we expect that these therapies will offer the greatest commercial opportunities. The advantages of allogeneic stem cell products over autologous products are that they have wider therapeutic applications and the batch to batch consistency means greater product reproducibility for clinical trial outcomes and widespread clinical use. The opportunity for batch production also significantly lowers costs compared with patient-specific autologous products and pricing is critical to both patient accessibility and therapy development. Currently approved allogeneic stem cell therapies include remestemcel-l (Mesoblast) for graft-versus-host disease and Cartistem (Medipost). To develop stem cell therapies on a commercial scale it s essential that stem cell populations can be expanded successfully. Much work has been done to expand the growth of stem cells from classical cell culture flasks to novel multilayer vessels, microcarriers and bioreactors; however cell expansion still remains a major challenge. Many biotech and pharma companies are developing their own proprietary processes to facilitate this and, in addition, are developing technologies for cryopreservation. Due to the importance of cell expansion and cell preservation we expect this to be an area of considerable innovation in the coming years. Overall, despite the complexity of many diseases and the risks involved in developing stem cell therapies, the pace of research in this industry continues to increase, with new advances announced regularly. It will be interesting to monitor this field over the coming decade to see if its considerable potential can be realised. 11
12 United States 5 Vanderbilt Avenue 11th Floor New York NY USA United Kingdom Christchurch Court Newgate Street London EC1A 7AZ United Kingdom Japan Kotakudo Ginza Building, 7th Floor Ginza Chuo-ku Tokyo China 16F Nexxus Building 41 Connaught Road Hong Kong Australia Level 7 10 Sussex Street Sydney NSW Citeline 015. All rights reserved. Citeline is a trading division of Informa UK Ltd. Registered office: Mortimer House, Mortimer Street, London W1T3JH, UK. Registered in England and Wales No Citeline provides the world s most comprehensive and reliable real-time R&D intelligence to the pharmaceutical industry, covering global clinical trial, investigator and drug intelligence. Our data is meticulously curated from over 30,000 unique sources by the industry s largest team over 50 full-time expert analysts and editors. Citeline s therapeutic area analysts and product managers regularly produce reports on key aspects of the industry, new therapy developments and relevant trends. Enjoy free access to these insights by downloading our latest reports and whitepapers at
RITMIR024 - STEM CELL RESEARCH IN CARDIOLOGY
1. SCOPE AND METHODOLOGY 2. REPORT SYNOPSIS 2.1 General Definitions Myoblasts Pluripotent Cells Multipotent Cells Progenitor Cells Role of Stem Cells in Repairing the Heart Stem Cell Therapy Stem Cells
More informationThe Types of stem cells: Totipotent Pluripotent Multipotent
Stem Cells is the main material for building and regeneration of the body Stem cells are not differentiated and can transform to any cell of organism Stem cells are capable of indefinite renewal through
More informationDemystifying Stem Cells. Brent Bost M.D., CPA, MBA, FACOG
Demystifying Stem Cells Brent Bost M.D., CPA, MBA, FACOG Disclaimers Author currently serves on Board of Directors of CordTrack Most applications discussed today are not currently FDA approved and are,
More informationSTEM CELL FELLOWSHIP
Module I: The Basic Principles of Stem Cells 1. Basics of Stem Cells a. Understanding the development of embryonic stem cells i. Embryonic stem cells ii. Embryonic germ cells iii. Differentiated stem cell
More informationSan Diego Stem Cell Treatment Center Frequently Asked Questions
San Diego Stem Cell Treatment Center Frequently Asked Questions What is a Stem Cell? A stem cell is basically any cell that can replicate and differentiate. This means the cell can not only multiply, but
More informationyour complete stem cell bank
your complete stem cell bank HYDERABAD - 88985 000 888, WARANGAL - 8297 256 777 VISAKHAPATNAM - 7799 990 774 VIJAYAWADA AND GUNTUR - 7799 990 771 NELLORE - 7799 990 772, KADAPA - 8297 256 700 RAJAHMUNDRY
More informationIt s not something you want to think about, but it s something you want to prepare for.
It s not something you want to think about, but it s something you want to prepare for. StemCyte cord blood banking offers your family a new lifesaving treatment alternative Why Bank Take the once-in-alifetime
More informationMESENCHYMAL STEM CELLS ADVANCES & APPLICATIONS
MESENCHYMAL STEM CELLS ADVANCES & APPLICATIONS TABLE OF CONTENTS 1. EXECUTIVE SUMMARY.p.12 2. REPORT OVERVIEW..p.14 2.1 Target Demographic 2.2 Key Findings 2.3 Statement of the Report 2.4 Purpose 2.4.1
More information5 Frequently Asked Questions About Adult Stem Cell Research
5 Frequently Asked Questions About Adult Stem Cell Research Stem cells are often referred to in the sociopolitical realm with some level of controversy and beyond that, some level of confusion. Many researchers
More informationSTEM CELLS FROM THE UMBLICAL CORD BLOOD AND UMBLICAL CORD TISSUE
STEM CELLS FROM THE UMBLICAL CORD BLOOD AND UMBLICAL CORD TISSUE What are Stem Cells? Stem cells are the basic building blocks of all the cells, tissues and organs in the human body. The role of the stem
More informationSTEM CELL FACTS. The ISSCR is an independent, nonproft organization providing a global forum for stem cell research and regenerative medicine.
STEM CELL FACTS The ISSCR is an independent, nonproft organization providing a global forum for stem cell research and regenerative medicine. WHAT ARE STEM CELLS? Stem cells are the foundation cells for
More informationPhone: +44 20 8123 2220 Fax: +44 207 900 3970 office@marketpublishers.com http://marketpublishers.com
Global Stem Cell Umbilical Cord Blood (UCB) Market (Storage Service, Therapeutics, Application, Geography) - Size, Share, Global Trends, Analysis, Opportunities, Growth, Intelligence and Forecast, 2012-2020
More informationDo you have anything to add? If so, I d love to hear from you! Jessica Robinson Conference Manager Life Sciences @jessbiopharma
1 Who is the most influential figure in cord blood around the world? What is the biggest challenge to overcome in the use of cord blood as a source of stem cells? We asked 10 leading experts in the cord
More informationThe Cell Therapy Catapult UK Clinical Trials Database
May 2015 The UK Clinical Trials Database covers cell therapy clinical trial activity that the Cell Therapy Catapult believes to be ongoing in the UK as of May 2015. It supersedes the database of April
More informationStem Cells and Inner Ear Cell Regeneration. Stefan Heller Stanford University School of Medicine
Stem Cells and Inner Ear Cell Regeneration Stefan Heller Stanford University School of Medicine Embryonic stem cells Induced pluripotent stem cells Somatic stem cells 50 µm Derived from the inner cell
More informationBackground Information
Background Information 1. What are stem cells? 2. What might stem cell research achieve? 3. Why we need to continue research using embryonic stem cells? 4. Time taken for discoveries 5. Examples of stem
More informationTop Ten Things to Know About Stem Cell Treatments
Top Ten Things to Know About Stem Cell Treatments Many clinics that are offering stem cell treatments make claims about what stem cells can and cannot do that are not supported by our understanding of
More information4. All cord blood banks should be subject to the same standards, regulations and accreditation requirements.
WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage The WMDA Board adopted this policy on 25 th of May 2006. Policy updated _April 2011 The Cord Blood Working Group and
More informationStem Cell Banking. Umbilical Cord. The Leading Cell Bank www.stemology.co.uk. Protect your family s future
Protect your family s future The Leading Cell Bank www.stemology.co.uk Stem Cell Banking Umbilical Cord For women in their 1st, 2nd or 3rd Trimester of Pregnancy Introduction to Stemology Imagine you
More informationBriefing on the second reading of the Human Fertilisation and Embryology Bill, Monday 19 November 2007.
Briefing on the second reading of the Human Fertilisation and Embryology Bill, Monday 19 November 2007. Prepared by the Medical Research Council, Royal Society and Wellcome Trust The Medical Research Council,
More informationStem Cell Research: Adult or Somatic Stem Cells
Chiang 1 Stem Cell Research: Adult or Somatic Stem Cells Abstract Kelly Chiang Cluster 7 Dr. LeFebvre 07/26/10 Over the past few decades, stem cells have been a controversial topic in the scientific field.
More information15 Stem Cell Research
15 Stem Cell Research t a l k it o v e r 1 c l a s s se s s i o n Overview Students read about current scientific research on and the social controversy over embryonic stem cells. On a KWL literacy strategy
More informationThe Cell Therapy Catapult
The Cell Therapy Catapult Keith Thompson CEO January 29 2013 info@ct.catapult.org.uk Catapult is a Technology Strategy Board programme The Launch of Catapults Hauser 2 Hauser Report Creating new manufacturing
More informationguides BIOLOGY OF AGING STEM CELLS An introduction to aging science brought to you by the American Federation for Aging Research
infoaging guides BIOLOGY OF AGING STEM CELLS An introduction to aging science brought to you by the American Federation for Aging Research WHAT ARE STEM CELLS? Stem cells are cells that, in cell cultures
More informationStem cells possess 2 main characteristics: Sources of pluripotent stem cells: -Long-term self renewal. -The inner cell mass of the blastocyst.
Stem cells possess 2 main characteristics: -Long-term self renewal. - They give rise to all types of differentiate cells. Sources of pluripotent stem cells: -The inner cell mass of the blastocyst. - Fetal
More informationAlexander Smolyaninov,
«German-Russian Forum Biotechnology and Life Sciences» September, 2006 St. Petersburg Center of Cell and Gene Therapy «CRYOCENTER SAINT PETERSBURG» Stem Cell Bank «POKROVSKI» Alexander Smolyaninov, M.D.,Ph.D.,
More informationSaving Cord Tissue for Your Family
Saving Cord Tissue for Your Family Dear Future Mom and/or Dad, All of us at CorCell would like to give you a big CONGRATULATIONS on your pregnancy! Now that you are expecting, you have probably heard about
More informationTERUMO Corporation Business Strategy Conference
TERUMO Corporation Business Strategy Conference THERAPEUTIC SYSTEMS & CELL PROCESSING MARK FLOWER GLOBAL MARKETING December 5, 2011 Regenerative Medicine, Cell Therapy, & Cell Processing Regenerative Medicine
More information[Indian Stem Cell Banking Market: Trends & Opportunities (2012-2017)]
[Indian Stem Cell Banking Market: Trends & Opportunities (2012-2017)] Executive Summary Stem Cells have a remarkable ability to develop in various body cells of a human. These occur in the earliest stages
More informationPT CordLife Indonesia Premium Cordblood Bank. PT CordLife Indonesia Premium Cordblood Bank
Cordblood Stem Cells and The Role of Cordblood Bank in Supporting Stem Cells Research Presentation Overview Company profile Haematopoietic stem cells in cordblood What we can do to help 1 2 PT CordLife
More information5. All cord blood banks should be subject to the same standards, regulations and accreditation requirements.
WMDA Policy Statement for the Utility of Autologous or Family Cord Blood Unit Storage (This policy statement has been approved and adopted by the WMDA board on the 25 th of May 2006) The Cord Blood Registries
More informationVita 34 Parents Guide to umbilical Cord Blood Banking. secure first-class innovative
Vita 34 Parents Guide to umbilical Cord Blood Banking secure first-class innovative Contents INTRODUCTION 3 THERAPEUTIC USES OF STEM CELLS 4 STEM CELLS IN CANCER TREATMENT STEM CELLS IN THE TREATMENT OF
More informationStem Cell Quick Guide: Stem Cell Basics
Stem Cell Quick Guide: Stem Cell Basics What is a Stem Cell? Stem cells are the starting point from which the rest of the body grows. The adult human body is made up of hundreds of millions of different
More informationA Genetic Analysis of Rheumatoid Arthritis
A Genetic Analysis of Rheumatoid Arthritis Introduction to Rheumatoid Arthritis: Classification and Diagnosis Rheumatoid arthritis is a chronic inflammatory disorder that affects mainly synovial joints.
More informationI. REPORT FOCUS A. INTRODUCTION FUNCTIONS OF STEM CELLS STEM CELL APPLICATIONS STEM CELL MILESTONES DEFINITION AND IMPORTANCE STEM CELL DEBATE
I. REPORT FOCUS A. INTRODUCTION FUNCTIONS OF STEM CELLS STEM CELL APPLICATIONS STEM CELL MILESTONES DEFINITION AND IMPORTANCE STEM CELL DEBATE CONCLUSION B. STEM CELLS - THE BEGINNING OF ALL BLOOD CELLS
More informationSTEM CELLS : A THERAPEUTIC REVOLUTION JACQUES KADOCH ROBERT HEMMINGS MARINELA MANDRA
STEM CELLS : A THERAPEUTIC REVOLUTION JACQUES KADOCH ROBERT HEMMINGS MARINELA MANDRA OVO CLINIC I 8000 BLVD DECARIE, MONTREAL QC H4P 2S4 I 514.798.2000 I OVOCLINIC.COM 2 a therapeutic revolution As the
More informationGlobal Stem Cell Umbilical Cord Blood
Report Code: DI 14114 Global Stem Cell Umbilical Cord Blood (product Types, Application, Technology, End Users and Geography) Global Share, Size, Industry Analysis, Trends, Opportunities, Growth and Forecast,
More informationTherapeutic Potential of Cells Derived from Gestational Tissues: A coming of age. Dr Roisin Deane Cell Care Australia Pty Ltd
Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age Dr Roisin Deane Cell Care Australia Pty Ltd What are Gestational Stem Cells? Stem cells isolated from the gestational tissues
More informationRoche Position on Human Stem Cells
Roche Position on Human Stem Cells Background Stem cells and treating diseases. Stem cells and their applications offer an enormous potential for the treatment and even the cure of diseases, along with
More informationPolicy statement. Stem cell research
Policy statement Stem cell research Introduction For some people who survive a heart attack, the damage to their heart muscle can lead to debilitating heart failure, for which there is no cure. Nearly
More informationBrochure More information from http://www.researchandmarkets.com/reports/2860999/
Brochure More information from http://www.researchandmarkets.com/reports/2860999/ Stem Cells: Worldwide Markets for Transplantation and Cord Blood Banking (Projections for Stem Cell Use in Cancer, Alzheimer
More informationStem cells will change medicine as we know it. Are you ready? STEM CELL BANKING
Stem cells will change medicine as we know it. Are you ready? STEM CELL BANKING Stem cell banking with Store-A-Tooth is a unique investment in the health of your family. WHY BANK STEM CELLS? YOU PLAN FOR
More informationDiscover the Possibilities Born With Your Baby
Discover the Possibilities Born With Your Baby Your Simple Guide to Saving Cord Blood The Power and Promise The lifesaving power of cord blood and regenerative healing potential of cord blood and cord
More informationWhat we will discuss today
Umbilical cord blood banking It s Utility? Dr. Nita Radhakrishnan Pediatric Hematology Oncology Unit, Sir Ganga Ram Hospital, New Delhi What we will discuss today What are stem cells? What are the sources
More informationAnticancer Immunotherapy A New Weapon Against Cancer JON STEPHENS, MPHIL SENIOR ANALYST, ONCOLOGY
Anticancer Immunotherapy A New Weapon Against Cancer JON STEPHENS, MPHIL SENIOR ANALYST, ONCOLOGY A robust new approach Since its inception in the mid-0th century, chemotherapy has been the mainstay of
More informationPerspectives on HCT Program Challenges in a Changing Reimbursement Environment The good, the bad, and the ugly
Perspectives on HCT Program Challenges in a Changing Reimbursement Environment The good, the bad, and the ugly Richard T Maziarz, MD Oregon Health & Science Univ February 27, 2014 THE GOOD Provider Principles
More informationGene Therapy. The use of DNA as a drug. Edited by Gavin Brooks. BPharm, PhD, MRPharmS (PP) Pharmaceutical Press
Gene Therapy The use of DNA as a drug Edited by Gavin Brooks BPharm, PhD, MRPharmS (PP) Pharmaceutical Press Contents Preface xiii Acknowledgements xv About the editor xvi Contributors xvii An introduction
More informationUC Davis Institute for Regenerative Cures A facility supported by the California Institute for Regenerative Medicine
UC Davis Institute for Regenerative Cures A facility supported by the California Institute for Regenerative Medicine Naming Opportunities Opportunity No. Description/Features Gift Amount Institute for
More informationPatient Handbook on Stem Cell Therapies
Patient Handbook on Stem Cell Therapies Appendix I of the Guidelines for the Clinical Translation of Stem Cells www.isscr.org 2008, International Society for Stem Cell Research 2 Introduction We have all
More informationStem Cell Therapy. Treat your pain, improve your lifestyle and look after your wellbeing. What are stem cells?
(02) 9824 3044 LIVERPOOL NSW 2170 Stem Cell Therapy Treat your pain, improve your lifestyle and look after your wellbeing What are stem cells? Stem cells are cells that can differentiate into other types
More informationthe future in your hands imagine
the future in your hands imagine The promise of hope Carrie and Wilf s story... Quinn weighed in at a healthy 4397g at birth. His parents, Carrie and Wilf, had decided to store the umbilical cord blood
More informationIWK September 22, 2010. Cord Blood Program
IWK September 22, 2010 Cord Blood Program Discussion Topics Insception s core values and core purpose Insception s experience Umbilical Cord Blood Stem cell Uses Insception Services in a Hospital Partnership
More informationCompany Statistics. "... the adult stem cell space is being hailed as the next multibillion dollar market." - Cambridge Consultants
Neo Stem, Inc. is a company in transitional growth mode. Recent strategic acquisitions have positioned the company to become a leader in the cell-based therapy industry - one of the most promising and
More informationCord Blood Bank Business Plan
Cord Blood Bank Business Plan A sample of how to create a new program Produced by the AABB subsection: Cellular Therapy Business Management with major contributions by Nicole Omer TABLE OF CONTENTS Page
More informationStem Cells for Life. (301) 654-7070 www.facialart.com
Stem Cells for Life Dr. H. Ryan Kazemi Board Certified Oral & Maxillofacial Surgeon (301) 654-7070 www.facialart.com 4825 Bethesda Ave., #310 Bethesda, MD 20814 Researchers feel that stem cells could have
More informationThe therapies are focused in cardiovascular, orthopedics and neurological indications.
1 2 CescaTherapeutics is (to our knowledge) the first company to integrate all of the essential: 1. Cell friendly devices, 2. Proprietary cell formulations, and Strict clinical steps to ensure the autologous
More informationStem Cells and Hope for Patients
Stem Cells and Hope for Patients by Maureen Condic, Ph.D. Most Americans know someone afflicted with an incurable medical condition. The possibility of stem cell cures has given hope to many who face such
More informationThe Next Wave of Psoriasis Drug Programs: Targeting IL-17 and IL-23 PAMELA SPICER ANALYST, CNS, AUTOIMMUNE/INFLAMMATION, OPHTHALMOLOGY
The Next Wave of Psoriasis Drug Programs: Targeting IL-17 and IL-23 PAMELA SPICER ANALYST, CNS, AUTOIMMUNE/INFLAMMATION, OPHTHALMOLOGY 2 Psoriasis is a chronic inflammatory condition that primarily affects
More informationNovel Targeted Immunotherapy Approach for Metastatic Melanoma Under Phase 3 Investigation
Novel Targeted Immunotherapy Approach for Metastatic Melanoma Under Phase 3 Investigation Hans S. Keirstead President, NeoStem Oncology NeoStem Presented by GTC, a conference production company 626-256-6405
More informationORTHOPAEDIC RESEARCH AND INNOVATION DAY, April 6, 2015
ORTHOPAEDIC RESEARCH AND INNOVATION DAY, April 6, 2015 SAFETY STUDY OF INTRAVENOUSLY ADMINISTERED HUMAN CORD BLOOD STEM CELLS IN THE TREATMENT OF SYMPTOMS RELATED TO CHRONIC INFLAMATION Brian Mehling,
More informationCurrent Issues in Stem Cell Technologies. Lance D. Trainor, MD OneBlood, Inc.
Current Issues in Stem Cell Technologies Lance D. Trainor, MD OneBlood, Inc. Objective: The big picture of stem cell therapy Outline: Relevant definitions History of Stem Cell Therapy Hematopoietic Stem
More informationTHE PROMISE OF STEM CELL RESEARCH
THE PROMISE OF STEM CELL RESEARCH MALIGNANT OSTEOPETROSIS AUTOSOMAL RECESSIVE DENSE SCLEROTIC SKELETON HEMATOLOGIC ABNORMALITIES NEUROLOGIC ABNOMALITIES DEATH IN INFANCY OR EARLY CHILDHOOD SUCCESS RATE
More informationCORD BLOOD BANKING FAQ
CORD BLOOD BANKING FAQ Cord Blood & Stem Cells Q: What is umbilical cord blood (UCB)? A: Bone marrow, peripheral blood and UCB constitute the three primary sources of stem cells. Cord blood, which, until
More informationThe Commercial Development of Cell Therapy Lessons for the Future?
The Commercial Development of Cell Therapy Lessons for the Future? Survey of the Cell Therapy Industry and the Main Products in Use and Development Part 1: Summary of findings Paul Martin, Ruth Hawksley
More informationCompany Profile // May 2012
Company Profile // May 2012 1 Disclaimer This presentation has been prepared for the group of companies held by Clal Biotechnology Industries Ltd. (CBI or the Group ) and is provided to you solely for
More informationGlobal and China Stem Cell Industry Report, 2014-2017. Sep. 2014
Global and China Stem Cell Industry Report, 2014-2017 Sep. 2014 STUDY GOAL AND OBJECTIVES This report provides the industry executives with strategically significant competitor information, analysis, insight
More informationUmbilical Cord Blood Stem Cells Current Status & Future Potential
Umbilical Cord Blood Stem Cells Current Status & Future Potential Natasha Ali Assistant Professor Haematology Department of Pathology & Laboratory Medicine/Oncology The Aga Khan University Email: natasha.ali@aku.edu
More informationSaving Your Baby s Cord Blood
Saving Your Baby s Cord Blood An Important Pregnancy Decision 1-888-CORD BLOOD HEALTHY FUTURES ARE Born at CBR For every parent who wishes they could do more to protect their family s health, there s Cord
More informationDEPARTMENT OF BONE MARROW AND STEM CELL TRANSPLANT
www.narayanahealth.org DEPARTMENT OF BONE MARROW AND STEM CELL TRANSPLANT About Narayana Health City Narayana Health, one of India's largest and the world's most economical healthcare service providers
More informationThe Australian Stem Cell Handbook. What you should know about stem cell therapies: now and in the future
The Australian Stem Cell Handbook What you should know about stem cell therapies: now and in the future April 2015 The National Stem Cell Foundation of Australia The National Stem Cell Foundation of Australia
More informationReference: NHS England B04/P/a
Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation (HSCT) (All Ages): Revised Reference: NHS England B04/P/a 1 NHS England Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation
More informationTiGenix Business and Financial Update for the First Half of 2015
REGULATED INFORMATION TiGenix Business and Financial Update for the First Half of 2015 Leuven (BELGIUM) 15 September 2015 TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused
More informationDIABETES A chronic, debilitating and often deadly disease A global epidemic Diabetes in Africa
DIABETES A chronic, debilitating and often deadly disease Diabetes is a chronic condition that arises when the pancreas does not produce enough insulin, or when the body cannot effectively use the insulin
More informationUMBILICAL CORD BANKING. (formerly Unistem Biosciences Pvt.Ltd.)
UMBILICAL CORD BANKING (formerly Unistem Biosciences Pvt.Ltd.) INITIATIVES OF CELLUGEN BIOTECH PVT.LTD. (formerly Unistem Biosciences Pvt.Ltd.) UMBILICAL CORD BANKING UMBILICAL CORD STEM CELL THERAPY Stem
More informationCONSULTATION RESPONSE
CONSULTATION RESPONSE Department for Business, Innovation and Skills (BIS): Regenerative Medicine Call for Evidence Response by the Wellcome Trust Introduction 1. The Wellcome Trust is pleased to have
More informationThe Therapeutic Potential of Human Umbilical Cord Blood Transplantation for Neonatal Hypoxic-Ischemic Brain Injury and Ischemic Stroke
The Therapeutic Potential of Human Umbilical Cord Blood Transplantation for Neonatal Hypoxic-Ischemic Brain Injury and Ischemic Stroke a,b* b,c a a b b b b a b a b c 430 Wang et al. Acta Med. Okayama Vol.
More informationFDA approves Rituxan/MabThera for first-line maintenance use in follicular lymphoma
Media Release Basel, 31 January 2011 FDA approves Rituxan/MabThera for first-line maintenance use in follicular lymphoma Approval provides option that improves the length of time people with incurable
More informationProgressive Care Insurance for life A NEW TYPE OF INSURANCE
Progressive Care Insurance for life A NEW TYPE OF INSURANCE New Progressive Care from Sovereign Progressive Care is a type of insurance that is new to New Zealand. It s not a traditional all-or-nothing
More informationStem cell research ACADEMY STATEMENT. progress, hopes and concerns ACADEMY STATEMENT 16 JANUARY 2013
ACADEMY STATEMENT 16 JANUARY 2013 ACADEMY STATEMENT Stem cell research progress, hopes and concerns KUNGL. VETENSKAPSAKADEMIEN, BOX 50005, SE-104 05 STOCKHOLM, SWEDEN TEL +46 8 673 95 00, FAX +46 8 15
More informationFederal Funding for Technological Revolutions: Biotechnology and Healthcare Highlights
ADVANCED TE CHNOLOGY P ROGRAM The Advanced Technology Program Federal Funding for Technological Revolutions: Biotechnology and Healthcare Highlights April 2006 National Institute of Standards and Technology
More informationDelivering gene therapy to patients
Delivering gene therapy to patients FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements
More informationStem cell research and Parkinson's
Parkinson's research Stem cell research and Parkinson's T his information sheet looks at what stem cells are and why they are important for research into a cure for Parkinson s. It also discusses where
More informationStem cells and cellular therapies: from research to clinic. ns,, PhD Faculty of Biology University of Latvia
Stem cells and cellular therapies: from research to clinic Janis Ancans ns,, PhD Faculty of Biology University of Latvia Our cells Human body originates from one stem cell Conventional drugs Long history
More informationAn Introduction to Stem Cells
By Kirstin Matthews, Ph.D. An Introduction to Stem Cells Overview Stem cells are cells that have the potential to replicate themselves for indefinite periods and to divide, producing one of themselves
More informationSo, get comfortable and enjoy finding out what the greatest achievements and challenges are facing the industry today.
1 Who is the most influential figure in cord blood around the world? What do you think has been the biggest achievement within the cord blood sector? Which is the most important development in cord blood
More informationThe Facts about Cord Blood
The Facts about Cord Blood Dear Future Mom and/or Dad, All of us at CorCell would like to give you a big CONGRATULATIONS on your new baby! Now that you are expecting, you have probably heard about saving
More informationSupport Program for Improving Graduate School Education Advanced Education Program for Integrated Clinical, Basic and Social Medicine
Support Program for Improving Graduate School Education Advanced Education Program for Integrated Clinical, Basic and Social Medicine January 27, 2009 Dear Professors (representative) of departments, Subject:
More informationThe ethics of stem cell research and treatment
The ethics of stem cell research and treatment Bernard Lo, M.D. March 12, 2009 1 hesc: ethical controversies Moral status of embryo? Clearly a potential person Some believe a person with rights Is hesc
More informationBiosimilar Monoclonal Antibodies in the Pipeline: Major Players and Strategies
Biosimilar Monoclonal Antibodies in the Pipeline: Major Players and Strategies Fern Barkalow, Ph.D, Senior Analyst, Oncology Citeline One of the biggest challenges facing biosimilar drug developers is
More informationShould Stem Cells Be Used To Treat Human Diseases?
SAMPLE ESSAY C Should Stem Cells Be Used To Treat Human Diseases? Stem cells can be defined as undifferentiated cells that are generated during the development of the embryo. There are two functions ascribed
More informationThe Prospect of Stem Cell Therapy in Multiple Sclerosis. Multiple sclerosis is a multifocal inflammatory disease of the central
The Prospect of Stem Cell Therapy in Multiple Sclerosis Multiple sclerosis is a multifocal inflammatory disease of the central nervous system that generally affects young individuals, causing paralysis
More informationStem Cell Research in India: Emerging Scenario and Policy Concerns
RIS Research and Information System for Developing Countries www.ris.org.in/abdr.html Asian Biotechnology and Development Review Vol. 8 No. 3, pp 43-53 2006, RIS. All rights reserved 43 Printed in India
More information5HJHQDWLYH 0HGLFLQH,QGXVWU\ LQ -DSDQ
(updated:2015/5/18) Rapid Growth of the Japanese Regenerative Medicine Industry Japan is the second-largest pharmaceutical market (2012) in the world after the United States. METI estimates the market
More informationOne of the most important recent developments in cancer treatment has been the ability to harvest stem
BIOTECHNOLOGY A Patient-Friendly Approach to Human Cell Transplantation One of the most important recent developments in cancer treatment has been the ability to harvest stem cells from bone marrow or
More informationStem Cells Market Trends based on Primary Industry Analysis
GENReports: Market & Tech Analysis Stem Cells Market Trends based on Primary Industry Analysis > Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US enal@selectbio.us > Gary Oosta,
More informationRoche s marketing applications for review of OCREVUS (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
Media Release Basel, 28 June 2016 Roche s marketing applications for review of OCREVUS (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA OCREVUS is the first investigational medicine
More informationPART I. SECTION 1. The legislature finds that an estimated. 128,000,000 Americans suffer from the crippling economic and
HOUSE OF REPRESENTATIVES TWENTY-FOURTH LEGISLATURE, 2007 STATE OF HAWAII A BILL FOR AN ACT RELATING TO MEDICAL RESEARCH. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII: PART I SECTION 1. The legislature
More informationWhat are Stem Cells? How can they be used in medicine?
What are Stem Cells? How can they be used in medicine? What is a stem cell????... What is a stem cell????......a cell with the ability to differentiate into specialized cells and renew to become more stem
More informationUMBILICAL CORD BLOOD, STEM CELL BANKING
UMBILICAL CORD BLOOD, STEM CELL BANKING Dr.Sharad Jain MD Blood Transfusion officer, & I/C Transfusion Medicine NSCB Medical College. Jabalpur.MP. Introduction: Every parent during childbirth DREAMS the
More information