CryoSave does not believe in marketing UCBSCs as a quick-fix solution to everything – Bio Spectrum India
As appeared in BioSpectrum, Volume 15, Issue 6, June 2017
Blood stem cell transplants have come a long way with a disease-free survival rate in the range of 90% in patients with optimal conditions. However, use of Umbilical Cord Blood Stem Cells (UCBSCs) in regenerative medicine is not mainstream yet. In an interaction with BioSpectrum Roderick M Stuart, Managing Director, CryoSave shared different aspects of UCBSCs.
How does your cryobanking facility operate globally?
The team at CryoSave believes that all expectant parents should consider ‘saving the cord’ given that umbilical cord is the source of young and potent stem cells that may contribute substantially in treatments of a growing number of diseases. We are contacted by an increasing number of expectant parents to avail the stem cell banking services for their to-be-born child. To ensure that more and more people are able to make an informed choice about stem cell banking, CryoSave circulates brochures in different birth centers, hospitals and clinics. Our team is available to meet the interested parents, share the details and clear all their doubts. Once the expectant couple decides to enroll for the services, they fill out the necessary forms and are assigned a unique ID along with a Natality kit box that is used for collecting the cord blood and maternal blood at the time of delivery.
The collection at the time of delivery is taken care of by the attending medical professionals with support from CryoSave’s phlebotomists (whenever needed). Traceability is paramount in our environment; this traceability is maintained from enrollment to delivery, transportation, processing, testing, preservation and release. CryoSave uses a specialist logistics service for transportation of cord blood from birth center to our lab in Whitefield Bangalore. The sample received at Bangalore undergoes a through physical check before undergoing processing. Cord blood is processed to separate the part that contains stem cells from the rest of the blood. It is important that cord blood processing is consistent, safe and sterile; we do this with totally automated processing that uses our proprietary protocol. There is an array of tests that is run on the maternal blood to ensure the safety of the preserved cells. The test results along with details of preserved stem cells are shared with the clients.
What procedure is followed for the storage of the cord blood samples in your laboratories?
The UCBSCs (umbilical cord blood stem cells) are cryopreserved in vapour phase of liquid nitrogen. The cryopreservation tanks are known as dewars. At CryoSave, after the processing step, we divide UCBSCs in parts to facilitate both future use and testing that may be required before use. The cells then undergo controlled rate freezing, which involves slowly bringing the temperature down, before being shifted to dewar for storage. Until we get the results of tests conducted on the maternal sample, we keep the UCBSCs in quarantine (that maintains the exact same conditions as the permanent storage). The UCBSCs are safely shifted to permanent storage after the test results are found to be favourable.
The initial period of storage is 21 years that may be extended eventually on client’s request.
The CryoSave lab maintains control samples (similar to the preserved specimens) that undergo stability check periodically. UCBSCs are preserved at temperatures below -180⁰C. It is theorized that at such low temperatures, if preserved properly, the cells can survive for decades or more. Efficient recovery of stem cells has been demonstrated from 23.5 years old sample, another such report of recovery from 30 year old sample is expected in coming years.
In what form are these cord blood samples stored and then used?
The fraction of cord blood that contains nucleated cells is preserved. The cryopreserved cells are in a frozen form, these need to be thawed before treatment. But before thawing comes the meticulous process of determining the match using HLA testing (if applicable), deciding on the transplant date, testing the preserved UCBSCs to ensure they are fit for transplant and transporting the UCBSCs to the location in cryoshippers that maintain the dewar-like cryogenic environment while transit. The medical professionals conducting the transplants generally use HLA for matching, TNC (Total Nucleated Cells) count and the viability of the preserved cells to make a recommendation.
Are there any limitations associated with these cord blood stem cells?
UCBSCs are associated with benefits like ease of collection, no risk for the mother or the baby, ready availability, lower incidence of transplant related complications and high probability of use in case of partial matching however the fixed volume that can be collected at birth is a limitation that may result in slower engraftment at the time of use.
CryoSave does not believe in marketing UCBSCs as a quick-fix solution to everything, we are responsible in listing out the facts and evidence-based information for the expectant couples. The would-be parents should consider evidence-based information before making a decision and we try to help them in this endeavor.
Are there any limitations associated with these cord blood stem cells?
At CryoSave, we understand the value of stem cells we preserve, so we go all out in making sure the end result is high quality and safe. We have a strict inclusion criteria that requires passing multiple checks and tests. Our processing is completely automated to minimize chances of any type of human error or contamination. Our lab is designed to ensure sterility and our processing does not require us to use any chemical.
We run over 26,000 environmental checks and over 6.3 million temperature checks annually to ensure safety while processing and in storage. We also run a parallel alternate monitoring system in our lab to be absolutely sure of the safety of cells that are processed and preserved.
What are the ethical issues or concerns associated with stem cell banking?
The ethical issues or concerns are associated with embryonic stem cells. At CryoSave we only preserve stem cells sourced from umbilical cord. These stem cells are ethically sourced with due consent from the parents. The collection of umbilical cord after birth does not affect the mother or the newborn in any adverse way. If not used to harvest stem cells, the umbilical cord would be treated as medical waste. CryoSave has no intention of being involved in embryonic stem cells.
How often does your bank release samples for carrying out treatments?
CryoSave Group has released 17 samples globally (14 for treatments and 3 for diagnostics). The released cells have been used for conditions like aplastic anemia, medulloblastoma, cerebral palsy, beta thalassemia major, congenital immunodeficiency, acute lymphoblastic leukemia etc.
In case of a requirement, the client and the treating doctor send us a signed request for the cells accompanied with the details of the condition, the decided date of use and the facility where the process would take place. Our Medical Director stays in touch with the treating doctor during this time.
What is the success rate so far of using stem cell therapy in the field of regenerative medicine?
Blood stem cell transplants have come a long way with a disease-free survival rate in the range of 90% in patients with optimal conditions. However, use of UCBSCs in regenerative medicine is not mainstream yet. The areas of regenerative medicine research include Autism Spectrum Disorders, Cerebral Palsy, Stroke, Type I Diabetes and others. It is expected that 1 in 3 people may benefit from regenerative medicine in their lifetime. CryoSave understands that this opportunity in regenerative medicine is based on availability of high quality cells. That is why we ensure continuity in our processes, consistency in our systems and responsibility in our overall approach towards stem cell banking.