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# Untitled Letter to Minneapolis Regenerative Medicine
- URL: https://www.fdaweb.com/untitled-letter-to-minneapolis-regenerative-medicine/
- Published: 2023-04-03T12:00:00.000Z
- Updated: 2026-09-14T18:23:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154119

CBER’s Office of Compliance and Biologics Quality has issued an [untitled letter](https://www.fda.gov/media/166796/download?ref=fdaweb.com) to Minneapolis Regenerative Medicine, objecting to claims and statements made on the firm’s Web site and marketing materials. The letter says the cellular product is marketed for treating various diseases or conditions, such as osteoarthritis and rheumatoid arthritis, but the firm has not obtained a BLA as required under the agency’s regulations. Examples of claims being made by the company include:

- “We utilize human umbilical cord tissue in our cell therapy... This tissue contains day 0 undifferentiated mesenchymal cells, meaning they have the potential to serve a variety of different functions based on the body’s need for repair. For example, if you receive an injection of our medicine for a knee affected by osteoarthritis, the cells will differentiate to help rebuild the damaged cartilage tissue in the joint space.”
- “Our Minneapolis Regenerative Medicine clinic knows that proper cell-based therapies can address the root cause of the problem, do not mask the pain, and utilize your body’s built-in repair system for a more natural way to address your pain...Whether its knee pain, arthritis, or a myriad of other conditions, Minneapolis Regenerative Medicine can help you overcome these issues naturally!”