Collection, Processing, and Banking of Umbilical Cord Blood


Indication

Phase

Institution

Enrollment

Clinical trials indicator

Autism

Phase II

Sutter Health

30

NCT01638819

Cerebral palsy

Phase I/II

Georgia Health Sciences University

40

NCT01072370

Cerebral palsy

Phase II

Duke University Medical Center

120

NCT01147653

Hypoplastic left heart syndrome (HLHS)a

Phase I

Duke University Medical Center

20

NCT01445041

Neonatal hypoxic ischemic encephalopathy

Phase I

Duke University Medical Center

25

NCT00593242

Pediatric stroke

Phase I

Children’s Memorial Hermann Hospital; University of Texas Health Science Center—Houston

10

NCT01700166

Traumatic brain injury

Phase I/II

University of Texas Health Science Center, Houston

10

NCT01251003

Type I Diabetesb

Phase I

University of Florida

15

NCT00873925

Type I Diabetesb

Phase I/II

University of Florida

23

NCT00305344


aCord blood stem cells are being evaluated for their potential to ameliorate neural injury resulting from HLHS as well as their potential to contribute to enhancing cardiac function

bBoth studies evaluating the use of cord blood in the treatment of Type 1 Diabetes demonstrated safety and feasibility, although they failed to show significant preservation of C-peptide levels in participants



Each cord blood bank is responsible for establishing its own recommendations for thawing of the CB unit. Broadly speaking CB is generally recommended to be thawed by a modification of the method described by Rubinstein et al. [46] with a single wash, followed by immediate infusion or injection at the bedside. It is interesting to note that recent guidelines from the FACT (Foundation for the Accreditation of Cellular Therapy) regulatory body now recommend additional washing steps for those units that are not RBC-depleted or -reduced to minimize DMSO toxicity in the recipient as well as to prevent hemoglobin overload due to RBC lysis upon thawing (as found in the 2013 AABB SmartBriefs). FACT now requires additional planning to accommodate this possibility in younger patients. We have found that it requires more skill and technical expertise to thaw and infuse a RBC-replete unit than it does an RBC-depleted unit.



5 Conclusions


As described above, the collection, processing, and banking of CB for immediate or future clinical use can be reproducibly performed with the proper methodology. It is important that all procedures used in the banking endeavor pass regulatory scrutiny. Regulatory compliance may increase operational costs but is essential in providing the assurance to clients and the treating physician that the cord blood unit is collected, processed, and cryopreserved under proper conditions, ensuring that the quality of the CB unit will be unchanged during long-term storage.

CB is being used with increasing frequency in hematopoietic stem cell transplants [64] facilitated in part by the establishment of large repositories of CB collected and cryopreserved for future use. CB donation to public banks has been integral to the over 30,000 estimated worldwide unrelated allogeneic cord blood transplants [9] while private (family) banks provide storage of cord blood for related allogeneic autologous use. Efforts are being made to extend the use of CB in HSC transplants including double cord blood transplants and expansion technologies which aim to overcome cell dose limitations in adult recipients [9].

Although many individuals over the past 20 years have elected to collect and bank cord blood for its potential use in the treatment of hematopoietic cancers and genetic blood and immune disorders, more and more, individuals are now taking advantage of the ability to bank cord blood for uses that are only now being realized or have yet to be discovered. Primarily, these stem cell applications are in tissue engineering and regenerative medicine. Regenerative medicine has the potential to treat many of the most common diseases by replacing or repairing malfunctioning tissues and organs. Because regenerative medicine focuses on functional restoration of damaged tissues, not just the abatement or moderation of symptoms, this field has the potential to cut healthcare costs significantly. However, in order for the promise of regenerative medicine to be realized, it is necessary to identify optimal stem cell sources for particular disease states, and make efforts to inform the lay and medical communities as to their options.

Already the therapeutic potential of CB stem cells to treat patients with neurologic and orthopedic issues, autoimmune diseases, and those suffering from the side effects of transplantation is being evaluated in clinical trials (Personal Communication from CBR and [65, 66]; see Table 24.1). Other trials will surely rapidly follow, including therapies for the eye, joints, and wound healing. In the next decade there will likely be additional uses that are not yet anticipated. The key to these advances is thought to lie in the paracrine effects of CB stem cells, and their ability to be used in many cases under the practice of medicine, since it appears in many instances that it is possible to merely infuse the stem cells directly without timely and costly in vitro culture and differentiation. That is why, in my opinion, CB stem cells are likely to become the preferred source of stem cells for many regenerative medicine applications, now and in the future.


Acknowledgements

I would like to acknowledge the invaluable technical assistance obtained from all of the Cord Blood Bank personnel that have made this review possible. I would also like to acknowledge the numerous physicians, midwifes, and nurses that have participated in the collection of the cord blood and tissue units. In addition, the author gratefully acknowledges the assistance of Katherine S. Brown and Heather Brown at Cord Blood Registry in the preparation of this manuscript.


Conflict of Interest 

The author is a consultant to CBR Systems, Inc. and Chief Science Officer for Adicyte, Inc.


References



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Mar 22, 2018 | Posted by in BIOCHEMISTRY | Comments Off on Collection, Processing, and Banking of Umbilical Cord Blood
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