Kimera Labs Exosome Stem Cell Investigation

Between 2020 and 2023, the U.S. Food and Drug Administration sent two letters to Kimera Labs, a Miramar, Florida company that made exosome products and an amniotic fluid product. The FDA then closed the matter in June 2026. The Lyon Firm is now investigating consumer concerns about how those products reached patients and how they were marketed.

Contact our consumer protection lawyers to learn more about stem cell fraud and deceptive marketing cases.

What the FDA Investigated

The first letter, dated April 10, 2020, an untitled letter, said Kimera’s website and online videos promoted exosome products for conditions including Parkinson’s disease, multiple sclerosis, stroke, diabetes and spinal cord injuries. The FDA wrote that such products appear to be regulated as drugs and biological products, which generally need an approved license or an investigational new drug application before lawful marketing.

The FDA later issued a warning letter on September 1, 2023, after inspecting the Miramar facility in July 2022. The agency wrote that Kimera made exosome products called XoGlo and XoGlo Pro, plus an injectable amniotic fluid product called Amnio2X, and distributed them to practitioners and medical facilities nationwide.

It stated that none held an approved biologics license and that distribution continued after the 2020 letter. The FDA also cited manufacturing deviations involving more than 37,000 vials. They included unvalidated sterile processes and an uninvestigated positive sterility result for one lot, whose vials the firm distributed.

Kimera’s Response and the Outcome

Kimera, a privately held company, said in a January 2024 press release that it answered the warning letter and described its products as made for research use. On June 12, 2026, the FDA issued a close-out letter.

Based on Kimera’s statement that it had stopped making, selling and distributing the three products, the agency wrote that the violations appeared addressed. A follow-up inspection in August 2024 found no evidence of continued production or distribution. The FDA added that the letter does not prevent future action.

A close-out does not answer questions from patients who received these products earlier.

Did You Receive Kimera Products?

Exosome and amniotic injections often reached patients through outside clinics that did not name the manufacturer. If you or a family member paid for one, ask the provider for the product name and keep your receipts, consent forms and ads. Call The Lyon Firm at (513) 381-2333 or request a free, confidential case review. Time limits apply to legal claims, so acting quickly helps.

Common Stem Cell Fraud Claims

Consumer cases over stem cell and exosome treatments often raise questions about the following:

• Marketing that suggests treatment can cure or reverse serious conditions
• Unclear disclosure that a product lacks FDA approval
• Charges for treatments that patients say delivered little benefit
• Infections or reactions after an injection or infusion

Why Choose The Lyon Firm

The Lyon Firm represents consumers in stem cell fraud and deceptive marketing cases. For over 20 years, attorney Joseph Lyon has handled consumer class actions and mass torts across all fifty states.

Courts frequently appoint the Firm to leadership roles, and our work has helped secure relief for more than 50 million class members. The Firm has recovered more than $550 million for clients and class members.

The Lyon Firm is investigating consumer concerns and has not concluded that Kimera Labs, Inc. or any clinic or provider violated any law. Statements attributed to the FDA and Kimera come from public documents. FDA letters state the agency’s position and are not court findings.