Hippocrates, Cords and Quality

Transcription

1 Hippocrates, Cords and Quality Transfusion Medicine Resident Education Seminar April 3,2012 Renee Naiman, Director, Quality and Regulatory Affairs

2 Overview -Brief update of cord blood history and usage. -Quality as a concept over time. -Quality as it applies to Cord Blood collection and processing and how this compares and contrasts with Whole Blood.

3 What are Cord Blood Stem Cells? Two Types of Stem Cells Adult Embryonic Three Main Sources of (Hematopoietic) Adult Stem Cells Umbilical Cord Blood Peripheral Blood Mobilization Bone Marrow Umbilical stem cells have the ability to: develop into mature blood cells re-populate bone marrow generate other tissues, and organs to be used for cellular therapy treatments

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14 Hippocrates and Quality really? Hippocrates first determined that health is related to your body and mind, not superstition. He crafted the first quality manual for healthcare as an oath.. never do harm to anyone

15 Quality Management Evolution - Customers could select highest quality craft from artisan - Assembly lines created need to replicate quality in mass production. - Eli Whitney, Henry Ford, Carl Benz, Edwards Deming early quality leaders. Japan leads in 50 s and 60 s - ISO, AABB, FACT/Netcord proponents in our field. - Health Canada and FDA use basic quality elements and GMP as part of their compliance and licensing process. - Use to regulate Blood and Cells, Tissues and Organs. - Functions to ensure quality of product and safety for patients.. do no harm

16 AABB Quality System Essentials - Organization - Resources - Equipment - Agreements - Process Control - Documents and Records - Deviations and Nonconforming Products or Services - Internal and External Assessments - Process Improvement - Safety and Facilities

17 Process Overview: Cord Blood Banking Collection Processing Transplantation

18 Collection Medical History Questionnaire - Health history - Travel history - High risk activities Sample Tubes, Blood Bags - Labeling - Shipping and Storage Transportation -Temperature control - Tamper proofing

19 Collection Processing - After delivery, cord blood is extracted and collected in the collection bag. -Volume, sterility, cell counts viability

20 Processing Cord blood (CB) unit labeled and transported to Insception s facilities Cord blood (CB) unit labeled and transported to facility CB unit inspected and weighed. Insception staff will call you to confirm safe arrival CB unit inspected and weighed. I CB unit placed in specialized centrifuge CB unit placed in specialized centrifuge Yields a concentration of CB stem cells Yields a concentration of CB stem cells CB stem cells placed in protective (cryocyte) bag CB stem cells placed in protective (cryocyte) bag Cryocyte bag placed in long-term storage cassette Cryocyte bag placed in long-term storage cassette

21 Processing: Cryopreservation Cassette placed into controlled rate freezer (CRF) Cassette placed into controlled rate freezer (CRF) Cryocart used to transport CB unit from CRF to liquid nitrogen tank decrease transient warming events Cryocart used to transport CB unit from CRF to liquid nitrogen tank decrease transient warming events Cassette placed into vapor phase nitrogen tank Cassette placed into vapor phase nitrogen tank Studies have demonstrated that cord blood stem cells remain viable in storage for at least 24 years. Source: Broxmeyer HE. Cord blood hematopoietic stem cell transplantation. (May 26, 2010), StemBook, ed. The Stem Cell Research Community,StemBook,

22 Storage Facility Quality Elements Natural gas back-up generator UPS (battery back-up) Tank temperature and Liquid Nitrogen level alarms Security systems monitored 24/7 New external bulk supply tank installed

23 Future Transplantation Process -Parent or specialist request CB unit for treatment -Consent to release information is obtained from parents -Coordination between Cord Blood Program and Treatment Centre -Extensive Chart Review Process -CB unit is transported in a portable nitrogen tank -Simple IV infusion -Outcome of transplant follow up.

24 Units released for transplant Current data on the release of UCB units for transplantation and therapy from family cord blood banks in Canada Canadian Cord Blood Registry Cells for Life Cord Blood Bank of Canada Create Cord Blood Peristem Healthcord Hema Stem Therapeutics Insception Biosciences Lifebank Cryogenics Progenics Cryobank Stem Sciences Inc. Source: Parents guide to cord blood.

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27 Jesse s story No family history His tumor was treated. Cord blood stem cells were used to replace his bone marrow Canada s first autologous cord blood transplant 11 years later Jesse is thriving!

28 Regenerative Therapy Barrett had no family history of Diabetes He was infused with his own umbilical cord blood stem cells 60 days after diagnosis After 10 years of storage with Insception, Barrett s cord blood stem cells were high quality with excellent viability His transplant was a success

29 Barrett Today. 3 years after infusion. Barrett s insulin has been reduced from 60u to 5u daily His pancreas continues to function and his blood sugars are managed by exercise and diet

30 Thank you!...questions??