The Road Ahead
The single biggest hurdle faced in cell therapy and the perinatal tissue product market is technical. The manufacture of cell therapy biologics and perinatal tissue products has layers of complexity that are absent from other therapies.
Regulations vary based upon jurisdiction. For example, with the current regulatory environment in the United States, there are strict restrictions on the isolation and expansion of cells. Within the United States, pure MSC products are not able to be given to patients as no pure MSC cell product has been approved by the FDA at this time. With the existing regulatory environment in Panama, these pure MSC preparations are able to be given at our facility in Panama.
Within the regenerative medicine market in the United States, we have utilized what we have learned over the past 15 years in Panama to create perinatal tissue products that are regulated under 21 CFR 1271 and section 361 of the Public Health Safety Act. Defining and testing the quality of cell therapy products and perinatal tissue products is of utmost importance. The US regulatory market is experiencing some exciting transitions that can start expanding citizen’s access to new regenerate products and treatment plans. This includes the federal Right to Try law and, on a local level, Texas’ House Bill. We are actively working with the FDA to obtain regulatory approval for cell therapies in the US.