Traditionally used to treat blood disorders and help restore the immune system following chemotherapy or radiation, stem cells from umbilical cord blood are now being explored for advanced cell therapy. According to Parent’s Guide To Cord Blood Foundation, there are now at least 60 clinical trials exploring the potential for hematopoietic stems cells (HSCs) from umbilical cord blood to treat neurological conditions, infections, wounds, diabetes, and stroke. These and other potential new uses for cord blood could significantly broaden their role in medicine beyond the current 80+ FDA approved treatments.
During these exciting times in the evolution of advanced cell therapy, the FDA is taking a leadership role. They are working diligently to ensure the safety, purity, and potency of these complex new biological products. In the case of stem cells derived from umbilical cord blood, the FDA classifies certain uses as drugs. This classification applies to treatments of non-related individuals where stem cells perform different basic function(s) in the recipient than in the donor. The FDA regulates all drugs under strict manufacturing standards for the pharmaceutical industry, known as current good manufacturing practices (cGMP). These standards apply to advanced cell therapy that are regulated as drugs.
Biological products are more complex than traditional drug products made from chemical substances. The active component(s) in a biological product are more difficult to define than the chemical ingredients in a traditional drug. As a result, biological products are often defined by their manufacturing processes. As a result, the FDA monitors production from the early stages to ensure the final product turns out as expected. The FDA requires manufactures to thoroughly test, validate, and research any proposed changes to the manufacturing process, equipment, or facilities that could result in changes to the biological product itself.
Transitioning to New Manufacturing Standards
As companies like Cord for Life® prepare to support the commercialization of new advanced cell therapies derived from umbilical cord blood, we are transitioning to these FDA standards. The FDA thoroughly inspects facilities like Cord for Life® to ensure we are strictly following the cGMP requirements. Should there be any shortcomings in the manufacturing process, the FDA issues a Warning Letter advising the company to make necessary improvements to ensure full compliance. The FDA gives companies the opportunity to take corrective actions to fully address any deficiencies in the FDA Warning Letter. This oversight through facility inspections and FDA Warning Letters is critical to the safety and health of patients.
Preparing for the Future of Medicine
Companies can apply for an an Investigational New Drug (IND) or Biological License once they meet the FDA’s cGMP standards. Companies can ship product across state lines to support important clinical trials and approved therapies once the FDA grants approval. Cord for Life® is committed to helping advance medicine through stem cell therapy and has worked hard on complying with the standards to ensure the safety, efficacy, and purity required. As we transition from the FDA standards for cord blood processing to their standards for drug manufacturing, we rely on their guidance and support.
- Recruiting Clinical Trials of Cord Blood or Umbilical Cord Tissue, Parent’s Guide to Cord Blood Foundation.