Abstract

Cord blood (CB) is either donated to public CB banks for use by any patient worldwide for whom it is a match or stored in a private bank for potential autologous or family use. It is a unique cell product that has potential for treating life-threatening diseases. The majority of CB products used today are for hematopoietic stem cell transplantation and are accessed from public banks. CB is still evolving as a hematopoietic stem cell source, developing as a source for cellular immunotherapy products, such as natural killer, dendritic, and T-cells, and fast emerging as a non-hematopoietic stem cell source in the field of regenerative medicine. This review explores the regulations, standards, and accreditation schemes that are currently available nationally and internationally for public and private CB banking. Currently, most of private banking is under regulated as compared to public banking. Regulations and standards were initially developed to address the public arena. Early responses from the medical field regarding private CB banking was that at the present time, because of insufficient scientific data to support autologous banking and given the difficulty of making an accurate estimate of the need for autologous transplantation, private storage of CB as “biological insurance” should be discouraged (1, 2, 3). To ensure success and the true realization of the full potential of CB, whether for autologous or allogeneic use, it is essential that each and every product provided for current and future treatments meets high-quality, international standards.

Highlights

  • Following the first cord blood (CB) transplant for hematopoietic reconstitution [4], 27 years ago in France for a child with Fanconi Anemia, CB has moved rapidly from an experimental stem cell source to a widely accepted alternative to marrow as a source of hematopoietic stem cells

  • The majority of CB products used today are for hematopoietic stem cell transplantation and are accessed from public banks

  • This review explores the regulations, standards, and accreditation schemes that are currently available nationally and internationally for public and private CB banking

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Summary

Sue Armitage*

MD Anderson Cord Blood Bank, Department of Stem Cell Transplantation, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Cord blood (CB) is either donated to public CB banks for use by any patient worldwide for whom it is a match or stored in a private bank for potential autologous or family use. The majority of CB products used today are for hematopoietic stem cell transplantation and are accessed from public banks. This review explores the regulations, standards, and accreditation schemes that are currently available nationally and internationally for public and private CB banking. To ensure success and the true realization of the full potential of CB, whether for autologous or allogeneic use, it is essential that each and every product provided for current and future treatments meets high-quality, international standards. Specialty section: This article was submitted to Hematology, a section of the journal

INTRODUCTION
Cord Blood Banking Standards
CORD BLOOD BANKING
CORD BANKING REGULATIONS
CORD BLOOD BANKING STANDARDS
Findings
CONCLUSION

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