By: Matthew Fischer
Iowa Senator Chuck Grassley issued a press release last week indicating that he sent a letter to the leadership of the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) seeking additional information regarding the investigation into U.S. Stem Cell Clinic, LLC based in Sunrise, Florida. The letter poses seven questions with a deadline of April 27th. Last November, the FDA issued new guidance regarding human cell and tissue based treatments and announced its intention to crackdown on unproven treatments. Hence, many in the industry are watching closely to see what actions if any have been taken.
In August 2017, the FDA issued a press release setting forth the details of a warning letter sent to U.S. Stem Cell Clinic, LLC. The warning letter cited manufacturing deviations, efforts to impede an investigation, and issuance of a demand for corrective action. This step was taken as a result of several people experiencing blindness after receiving stem cell injections for treatment of macular degeneration. One of the patients noted that she believed the treatment was part of a clinical trial listed on ClinicalTrials.gov.Continue reading