Future Health Technologies. From Academia to Industry The Stem Cell Challenge. Roger J. Dainty MBE FIScT UK Managing Director

Transcription

1 Future Health Technologies From Academia to Industry The Stem Cell Challenge Roger J. Dainty MBE FIScT UK Managing Director

2 How Did I Get Here? Working as a Research Medical Technician (Birmingham University Medical School) Qualifications - ONC Chemistry Part Time - HNC Chemistry Part Time - HNC BSc Biochemistry Part Time - MSc Forensic Pathology Part Time (Nottingham University Medical School) MBE Research Science and Training Honorary Fellow of the Institute of Science and Technology (FIScT)

3 Employment Trainee Senior Medical Laboratory Scientific Officer (Birmingham Medical School) Chief Principal (MLSO) Biochemistry (University of Nottingham Medical School) Business Manager Biomedical Sciences Medical School (University of Nottingham NHS Industry) Managing Director Future Health Technologies (All UK Operations) Private HTA Accredited Cord Blood & Tissue Bank

4 Speciality skills included Medical Biochemistry Research Bench Skills Molecular Biology Cryogenic Skills Lecturing & Presentation Skills *(PCFE) Finance, HR and Personnel Management Skills Teaching Part-time lecturer at College of Further Education (City & Guilds lab technician) Molecular Biology to *European Social Fund for Technicians*

5 Experience European Social Fund (ESF) 2 year training course for unemployed people (ages 18-24) Full salary day release and in-house training to HNC level Total of 96 students over 7 years concluded with 92% job success rate Supported by ESF and University of Nottingham funding

6 Future Health Technologies 2000 Locate and build GMP laboratories Registered Ltd Company First Private Cord Blood Bank to achieve Medicines Healthcare Regulatory Agency (MHRA) First Private Cord Blood Bank to gain an Human Tissue Authority (HTA) Licence following the introduction of the European Guidelines Obtained full ISO 9001 Accreditation Queens Award For Enterprise 2011 Awarded MHRA Blood Establishment Authorisation

7 Future Health Technologies set up Buildings, regulations and GMP approval Staff employment Lab manager, Scientific officers, accountants, secretaries, lab aids Register company for MHRA / HTA / ISO 9001 accreditations Appoint company lawyers, employments contracts, etc. Safety officer and Human Resources support Insurances Formulate stem cell cryopreservation technologies

8 What do we do? Collect Cord Blood and Tissue from the placenta aseptically, after the baby is safely delivered. Transport samples back to FHT state of the art Laboratory s within 72 hours. Perform blood/viability and microbial testing. Reduce volume and separate stem cells/ tissue in grade B clean rooms Cryogenically store cells and tissue at -196 C for 25 years.

9 Cord Blood and Tissue Stem Cells Cord Blood and Cord Tissue is collected at the time of birth and sent to the Future Health Biobank labs for processing and cryopreservation. Collection is simple, painless and carries no risk to mother or baby. It does not interfere with the natural course of labour. Future Health Biobank provides inhouse microbiology and maternal blood testing.

10 The company is based in Nottingham Pharmaceutical heritage Courier connections The first private purpose built laboratory to be fully accredited by the MHRA of the UK Dept. of Health & licensed by the Human Tissue Authority (22503) Who are we?

11 What are stem cells?

12 Cord Blood Stem Cells Stem cells have the remarkable potential to develop into many different cell types in the body. Stem cells are the building blocks of the blood & immune system Umbilical cord blood is a rich source of stem cells which can go on to become: blood cells (Haematopoietic Progenitor Cells HPCs) (RBC, Lymphocytes, Platelets) other types of cells (Multi-lineage Progenitor Cells MLPCs) mesenchymal. ( Bone, Liver, Nerve)

13 Cord blood collection The blood is collected into a sterile bag, placed in a sealed container and sent in a thermal box by medical courier to Future Health s own laboratories in Nottingham. The sample is then tested, processed and stored according to UK and EU guidelines

14 The Collection Kit

15 Maternal blood tests Initial test performed at time of birth In house serology testing HIV 1& 2, Hep B, Hep C, VDRL, HTLV, CMV In house viral testing - PCR

16 In-house microbiology

17 Cord Blood processing Cells are processed in our own purpose built sterile clean rooms using scientific officers with a minimum of 6 months GMP training Closed system single use processing kits protect the sample from the environment They are cryopreserved using computerised controlled rate freezers

18 GMP laboratory

19 Swiss laboratory

20

21 Emergency back-up liquid nitrogen tank

22 Sources of Stem Cells Peripheral Blood & Bone Marrow Cord Blood Wharton's Jelly (Cord Tissue) Cord Endothelium (Cord Tissue) Placenta Adipose Tissue (Fat) Milk teeth from children

23 Mesenchymal Stem Cells Isolated from various sources including umbilical cord blood Capacity to differentiate into cells of connective tissue (bone, cartilage, fat, muscle) Potential use for tissue engineering Used in cardiovascular, neural & orthopaedic applications

24 Mesenchymal Cord Tissue Storage

25 Mesenchymal Stem Cells Adhere to Plastic

26 CD29 How do we characterize them? CD44 CD34 CD45

27 Potential uses of Stem Cells

28 Company New Products Dental Pulp

29 Company New Products Adipose

30 Summary We are now a leading provider of quality service in Europe and the Middle East Presence already established in the UK, Greece, Portugal, Bulgaria, Switzerland, Ireland, Serbia, Macedonia, Syria,France, Italy, Spain, Saudi Arabia, Dubai, Jordan, Cyprus, Romania, Qatar, Kenya, Kuwait, Lebanon and more.. Received over 90,000 samples from 60 different countries

31 Live case history - 1 Baby boy, diagnosed with Severe Combined Immunodeficiency ( SCID ), which usually results in the onset of one or more serious infections within the first few months of life. A suitable bone marrow donor could not be found. His older sister had her stem cells stored at birth, in 2011 with Future Health. Tests showed, that she was a match for her brother. The sample was sent from Future Health to the medical centre, and the transplantation was performed in early All preliminary results show the condition is improving.

32 Transplantation

33 Live case history - 2 Sixteen-year old Laith Abu Areesh suffers from Fanconi s Anemia, a condition that affects the bone marrow s ability to make healthy blood cells. Doctors said his best chance of recovery was a bone marrow transplant but extensive searches over the years had failed to find a donor match. New hope for Laith arrived in October 2010 with the birth of his baby sister. Her cord blood sample was a rich supply of the same stem cells, which are present in bone marrow and these proved to be a perfect match for her sick brother.

34 The sample was duly released from storage by Future Health at the end of April. The transplant took place at the King Hussein Cancer Centre in Jordan on Sunday 20th May, Transplantation

35 Transplantation Success Laith is now enjoying a healthy life for the first time in his life, and follow-up tests show that he is producing normal levels of red and white blood cells.

36 and also enjoying his football. Transplantation Success

37 Future Health Technologies My personal stem cell challenge Thank you Roger J. Dainty MBE FIScT