FDA Sends Warning Letter to a U.S. Manufacturer of an Unapproved Stem Cell Product

Regenerative medicine focuses on therapies that replace or restore lost, damaged, or aging cells in the human body to restore function. Stem cells have the potential to repair, replace and regenerate cells making them a powerful tool in the field of regenerative medicine. For years, in the United States, controversy and governmental regulations have restricted research in the field of regenerative medicine. In 2005, when Japan approved 3 billion dollars in government funding specifically for regenerative medicine research, and the Chinese government provided the equivalent of 1 billion dollars for the purpose of researching regenerative medicine, the United States government chose not to proactively support this field of research. As a result, the field of regenerative medicine in the United States lags behind many countries.

Countries in Central America, South America and Asia are leading the world in stem cell research and clinical trials. There are many clinics in the United States advertising stem cell therapy for many different degenerative diseases however, the only FDA government approved stem cell treatments include certain cancers and disorders of the blood and immune system.  In August of 2017, The FDA announced a crackdown on stem-cell clinics in the United States that are offering an “unapproved and potentially dangerous” treatment. As part of their increased oversight they took action against several clinics in California and Florida.

This year, on January 4, 2018, as part of the increased regulation of cell based therapies, the FDA sent a warning letter to the company CryoStem for, “marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.”1 During a recent inspection of the Cryostem facilities, the FDA discovered the company was manufacturing and marketing Atcell, an adipose derived stem cell product without FDA approval.  The FDA found the manufacturing steps could potentially introduce contamination of the product which could potentially harm patients.  The FDA also found the company was potentially utilizing an unvalidated manufacturing process in an inadequately controlled environment. Cryostem has 15 days to respond to the warning letter.  Should the company fail to respond appropriately, they may be subject to seizure, injunction and or prosecution.1

Studies conducted globally suggest that mesenchymal stem cells can be used to treat many degenerative disorders. The Stem Cells Transplant Institute in Costa Rica uses adult autologous stem cells to treat; Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, diabetes, lupus, rheumatoid arthritis, osteoarthritis, COPD, neuropathy, myocardial infarction, cardiovascular disease, aging, erectile dysfunction and critical limb ischemia. All treatments by the Stem Cell Transplant Institute are approved by the Costa Rican government.

Dr. Leslie Mesen, founder and CEO of the Stem Cells Transplant Institute, studied medicine at Universidad Iberoamericana (UNIBE) in San José, Costa Rica. Dr. Mesen is board certified in Anti-Aging and Regenerative Medicine by The American Academy of Anti-Aging Medicine and receives continuing education courses in both the United States and Latin America.

Physicians at the Stem Cells Transplant Institute utilize an FDA approved method and protocol for harvesting and isolating the adipose derived stem cells for autologous reimplantation. The mesenchymal stem cells are harvested from the patient’s own adipose tissue (fatty tissue) and then activated.  Stem cells isolated from adipose tissue have the ability to transform into many types of mature cells including adipose cells, bone cells, cartilage cells, heart cells, brain cells or liver cells. Once activated the cells are then administered back into the patient either by intravenous or intrathecal injection or by aerosol inhalation.

The experts at the Stem Cells Transplant Institute believe in the power of stem cell therapy but they also believe stem cell therapy needs to be conducted in a safe and well controlled environment. Patient safety and individualized patient care are our first priority. Contact us today to see if stem cell therapy is right for you.