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# Untitled Letter Sent Over Stem Cell Therapies
- URL: https://www.fdaweb.com/untitled-letter-sent-over-stem-cell-therapies/
- Published: 2019-05-31T12:00:00.000Z
- Updated: 2026-09-15T01:29:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144236

CBER’s Office of Compliance and Biologics Quality has sent an [untitled letter](https://www.fda.gov/media/126709/download?ref=fdaweb.com) to R3 Stem Cell because its Web site promotes its “regenerative stem cell therapies” without an approved BLA. “We note that your products are intended to treat a variety of serious or life-threatening diseases or conditions,” the letter said. “Such unapproved uses raise potential significant safety concerns. Additionally, because the products are administered by various higher risk routes of administration, including IV, their use, if contaminated could cause a range of adverse events.”