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The International Cell Medicine Society (ICMS) is a medical science not for profit organization composed of physicians, scientists, and laboratory personnel dedicated to the development and dissemination of laboratory and clinical guidelines for minimal culture expansion of autologous, adult stem cells (A-ASCs). The ICMS maintains a Clinical Best Practices Committee (CBPC) consisting of physicians and medical research scientists.
The CBPC began the process of guideline development by reviewing existing guidelines and other publications pertaining to the clinical translation of stem cells. Because most clinical translation publications and discussions have focused on the relatively greater risks of allergenic transplants such as umbilical cord blood and embryonic stem cells the CBPC had to essentially start from scratch in developing guidelines for the substantially smaller risk techniques used for A-ASC minimal culture expansion.
These guidelines were created to balance the minimization of risk with the availability of clinical care within the framework of current treatment paradigms for various conditions. For example, the risks of a hypothetical treatment for severe type II diabetes with A-ASC therapy would be weighed against the risks of conventional therapy as well as the risk of morbidity and mortality in untreated patients. Another example would be the risks posed by NSAID therapy in cases of orthopedic trauma (>60 days of therapy results in death in 1 in 1200) versus the risks and benefits of A-ASC therapy for the same condition. As part of this risk to benefit assessment the CBPC has had to include the type of tissue intended for treatment as the risk of therapy is proportional to the tissue receiving the treatment. For example, A-ASC transplants of orthopedic and cosmetic tissue carry less treatment risk than transplants involving cardiac and central nervous system tissue.
As a historical context, the evolution of In-vitro Fertilization (IVF) illustrates the development of a minimal culture expansion process. The first successful IVF procedures were performed in the late 1970’s. By the 1990’s fertility specialists had decided that extending cell culture to the blastocyst stage allowed them to improve conception outcomes by not only choosing the embryo that demonstrated the best in-vitro proliferation potential, but also by implanting a more mature cell mass into the patient. This marked the transition of IVF from a simple tissue transplant procedure to a cell culture technique. Further advances in genetic screening will likely require more extended cell culture methods, as cells from the growing blastocyst are usually sacrificed for genetic testing.
Fertility specialists have maintained that Assistive Reproductive Technology (ART) and the cell culture techniques that it uses are in fact the practice of medicine and not the production of biologic drugs. While the FDA has proposed regulations to regulate IVF clinics (21 CFR parts 50, 56, and 312-Oocyte cytoplasm transfer), it has failed to classify IVF culture as the production of a biologic drug. The CDC has published guidelines for Assistive Reproductive Technology (ART) clinics, intended to assist states in producing their own certification programs. However, federal oversight is not mandated for such clinics. As a result, the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology have put forth their own credentialing criteria for ART . Most ART labs are accredited through the College of American Pathologists’ Reproductive Laboratory Accreditation Program or through the Joint Commission on Accreditation of Healthcare Organizations. The ICMS approach to guidelines and ultimately credentialing development presented herein has been designed along the lines of the successful model developed by ASRM and SART for the clinical application of ART.
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