The Regulation of Hematopoietic Stem Cell Collection and Storage: The New York State Approach

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Abstract
In December 1988, the New York State (NYS) regulatory code on bone marrow banking went into effect. The goals of the regulations were to codify a high standard of practice, to prohibit charlatanism in the practice or promotion of stem cell banking, and to promote legitimate research. The NYS approach modeled the stem cell regulatory language after that already established for blood banks and clinical laboratories. Also, the stem cell standards are an element of standards applicable to all tissue banks, developed as a result of a comprehensive transplant law enacted in NYS in 1990. The code itself, published as an addendum to this article, mandates that a qualified (by training and experience) medical director and medical advisory committee be appointed, and gives broad and complete responsibility for the services provided to that medical director. Explicit written policies and procedures regarding administrative, technical, safety, and quality issues are necessary, but regulatory micromanagement of the laboratory was avoided by limiting detailed procedural requirements. We believe that these regulations have contributed to the quality and safety of stem cell-related therapies in NYS.