The Importance of Compliance When it Comes to Stem Cell Therapy

Stem cell therapy is basically the application of stem cells into a patient in order to treat a medical condition or disease. Since stem cells have the power to replace and/or repair damaged or dying cells in the body; stem cell therapy has become highly useful. Currently, the only approved therapy using stem cells as a medical remedy is stem cell transplant surgery. This typically involves a bone marrow transplant, but the stem cells can also be harvested from umbilical cord plasma. QC Kinetix (Round Rock)

There are many unapproved stem cell therapy products currently being sold for medical purposes. However, it is illegal to sell these products as ‘cosmoceuticals’ in most states. Although the sale and distribution of stem cells remain illegal, there are no laws mandating the use of unapproved stem cell products in clinical trials. Many stem cell clinics are selling stem cell products without getting FDA approval. These clinics can obtain stem cell products from a number of sources including the Hospice. Even some physicians who work at reputable medical research institutions such as hospitals and biotech companies are accepting payment for stem cell products without FDA approval.

One issue that all stem cell therapy clinics must contend with is the ability to get clinical trials conducted on their tissue culture systems. If a company can’t get these trials then they will not be able to get FDA approval for their product. Stem cell products can be very expensive, so clinics must keep a tight lid on the cost of these products while conducting clinical trials. In order to get these tests conducted and to get the FDA approval for the product, it is important to only purchase cells that are in compliance with the right conditions. Only after compliance can the company proceed with conducting clinical trials.