UMBILICAL CORD BANKING. (formerly Unistem Biosciences Pvt.Ltd.)

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1 UMBILICAL CORD BANKING (formerly Unistem Biosciences Pvt.Ltd.)

2 INITIATIVES OF CELLUGEN BIOTECH PVT.LTD. (formerly Unistem Biosciences Pvt.Ltd.) UMBILICAL CORD BANKING UMBILICAL CORD STEM CELL THERAPY

3 Stem Cells are undifferentiated biological cells that can differentiate into specialized cells and can divide (through mitosis) to produce more stem cells. WHAT ARE STEM CELLS?

4 CelluGen Biotech Pvt. Ltd. (Formerly Unistem Biosciences Pvt. Ltd.)

5 CELLUGEN BIOTECH PVT LTD. Provides a full spectrum of stem cell solutions, right from enrollment, collection, processing, cryopreservation, research and therapeutic applications

6 MyCord is a CelluGen Initiative (CelluGen Biotech Pvt. Ltd.) Pioneers since 2008, CelluGen is driven by a passion to explore the challenging field of regenerative medicine. Dedicated to the science of stem cell therapy by developing technologies and protocols for safe and effective treatments utilizing adult stem cells from the umbilical cord.

7 FACILITY Cellugen brings technical expertise and cutting edge equipment in a state-of-the-art facility comparable to the best in the world under one roof. Our quality control laboratory and the stem cell processing areas follow the strict guidelines of GMP, GTP and GLP. We stringently follow the guidelines of DCGI, ICMR, DBT, ISO-9001, US FDA, AABB and FACT-NETCORD The stem cell processing is performed in clean room conditions ranging from class 10,000 to class 100

8 ELIXCELL The knowledge on processing stem cells led CelluGen to expand its expertise into utilizing it for therapeutic applications. This initiative led to establishing ElixCell, which offers end to end stem cell solutions.

9 RESEARCH Our backbone is the groundbreaking research and standardizing protocols Safety of MSCs established at government approved laboratory, Intox Pvt. Ltd, Pune Therapy administered successfully using MSC s in more than 20 cases Currently researching ways to harness amniotic membrane for therapeutic purposes

10 First time in India Technological excellence in collecting, processing and storage of amniotic membranes Suitable for allogenic use MYCORD APPROACH AMNIOTIC MEMBRANE Tremendous potential for skin regeneration following injury and disease Research in advanced stage for treatment in corneal erosions, diabetic foot, non healing ulcers etc.

11 The right procedure determines the difference between a cell that is pure, viable, and potent at the time of actual use and the one that is cryogenically frozen but ineffective. The knowledge of having established therapy protocols led CelluGen to expand its spectrum of services into banking of umbilical cord stem cells MYCORD, keeping in mind the actual end-use of the stem cells.

12 NEED OF A PUBLIC CORD BLOOD BANK BONE MARROW/PERIPHERAL BLOOD HSC S UMBILICAL CORD HEMATOPOETIC STEM CELLS /6 MATCHING REQUIRED /6 MATCHING REQUIRED AUTOLOGOUS UMBILICAL CORD HSC s: Vast therapeutic potential more so in Regenerative medicine ALLOGENIC UMBILICAL CORD HSC s: Viable alternative to bone marrow and peripheral blood stem cells as perfect matching is not required

13 Global Umbilical Cord Blood (UCB) banking market was estimated at USD 13,515.8 million in 2014 and is expected to grow at a CAGR of 6.1% from 2014 to 2020, to reach an estimated value of USD 19,335.6 million in marked the 25th anniversary of the first umbilical cord blood (UCB) transplantation (UCBT) performed in France 2 In 27 years, the field of UCB banking and transplantation has grown exponentially. Over 600,000 UCB units have been stored for transplantation worldwide, and more than 30,000 UCBTs performed. 2 1: Source: Public Umbilical Cord Blood Banking in India Primary research report by Unistem 2. Appelbaum FR. Pursuing the goal of a donor for everyone in need. N Engl J Med Oct 18; 367(16):

14 Only 30% of patients who require an allograft will have a human leukocyte antigen (HLA)-matched sibling donor despite >20 million adult volunteer donors in the National Marrow Donor Program and affiliated registries. Therefore, UCB has gained popularity and acceptability as an alternative transplant source for patients lacking appropriate adult donors. 2 UCB transplant requires a 4/6 match as opposed to 6/6 match required for Bone marrow transplant UCB reduce graft-versus-host reactivity compared with adult-derived marrow grafts

15 There are at least 142 public banks worldwide. with just 3 in India Relicord, Jeevan Cord and Stemcyte which collectively have approx. 5,000 units. A booming birth rate of 26 million births per year and genetic diversity; the country would be poised to be the largest collector of UCB in the world Most patients of Indian origin who require bone marrow transplantation do not find a match McKenna D, Sheth J. Umbilical cord blood: Current status & promise for the future. Indian J Med Res 2011 Sep; 134:

16 INDIAN SCENARIO (CONTD.) In India, approximately 32 patients have been transplanted using related or unrelated UCB to date. This number is very low mainly due to negligible number of UCB units available (15 patients mainly for relapsed leukemia and aplastic anemia and approx.13 cases of thalassemia ) UCB transplantations are comparatively very less in India, mainly because of cost prohibition, and the public UCB banks being in early stage of development with insufficient UCB depository No financial support given by the central government of India in this sector in comparison to North America where over USD 80 Million has been contributed by their government

17 INDIAN SCENARIO (CONTD.) World India 600,000 units 5000 units 30,000 transplants 32 transplants

18 UMBILICAL CORD COLLECTION KIT COMPONENTS Surgical Gloves Insulator Pouch EDTA VACUITAINER - 3 SST PLAIN TUBES - 2

19 STERILIZED TRAY FOR COLLECTION Umbilical Cord Blood Banking: Implications for Perinatal Care Providers: MARCH JOGC MARS 2005

20 TAKE HOME MESSAGE Over UCB units have been stored for transplantation worldwide, and >30000 UCBTs have been performed. Only 30% of patients who require an allograft will have a HLA-matched sibling donor despite >20 million adult volunteer donors in the National Marrow Donor Program and affiliated registries. Since the first successful transplant in a child with Fanconi anaemia in 1988, UCB has emerged as a feasible alternative source of haematopoietic progenitor/stem cells for allogeneic transplantation.

21 TAKE HOME MESSAGE UCB has shown to be a viable alternative to Bone Marrow and Peripheral Blood. It requires less restrictions for matching, as the naïve immune system appears to cause less severe GVHD. Research has also shown that two different UCB units are not associated with crossed immunological rejection suggesting immunological mechanisms may facilitate engraftment in donors receiving two unrelated UCB units.

22 TAKE HOME MESSAGE There are at least 142 public banks worldwide with just three in India Relicord, Jeevan Cord and Stemcyte which collectively have approx. 5,000 units. There are 25 private UCB banks worldwide with 7 in India and several more likely to open in the near future. UCB transplantations are comparatively very less in India, mainly because of cost prohibition, and the public UCB banks being in early stage of development with insufficient UCB depository

23 TAKE HOME MESSAGE A booming birth rate of 26 million births per year and genetic diversity; the country would be poised to be the largest collector of UCB in the world Utilization of UCB stored in India extends to beyond India and match probability extends to Middle East and the entire Indian sub-continent In India and other countries private UCB banking dominates, limiting general public access to promising therapies.

24 THANK YOU