Today, the Food and Drug Administration (FDA) does not have federal mandatory regulations for autologous adult stem cell collection and preservation companies that collect, harvest or store adult stem cells from blood. The FDA does issue compliance guidelines for the cord blood and adult stem cell storage industry every year. In fact, due to the surge in cord blood and adult stem cell based services and products, it is anticipated that the FDA will formalize these evolving guidelines and establish mandatory regulations in the next few years.
This year the FDA issued a revised set of compliance guidelines for our industry called the “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”. These guidelines focus on the following areas for recommended compliance for how stem cells should be collected from individuals or humans:
- Donor-eligibility
- Reviewing communicable diseases
- Retain record information of donor testing
- Donor screening
- Requirements for donor testing
At AssureImmune, we are currently following the recommended compliance guidelines presented by the FDA for autologous adult stem cell and cord blood stem cell collection and storage. Even though this process is not mandatory in order to conduct our business, we are committed to following these guidelines for cord blood and adult stem cells banking storage to ensure that our client’s cells are safe. It is yet another commitment to our clients to assure that our processes, lab and equipment are compliant based on the FDA guidelines
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