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# Regenerative Medicine Designation for Alzheimer’s Therapy
- URL: https://www.fdaweb.com/regenerative-medicine-designation-for-alzheimers-therapy/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157326

FDA has granted Longeveron a Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B and its use for treating mild Alzheimer’s Disease. The allogeneic cellular investigational therapy is currently being evaluated across multiple indications, including Alzheimer’s (Phase 2a completed), aging-related frailty (Phase 2b completed) and hypoplastic left heart syndrome (Phase 2b ongoing). The designation is based on [data](https://www.globenewswire.com/Tracker?data=1TvubvER7ENZVEx0-1IrwlE7aLRWXNMb6Ol-UFpCB1UFZcgG%5FJbOi6PeH-faSUjxKoqkWOho5ZF17HdcxXvQ5rMA0FGDben4hPw0uRol05NgznyxTwStaerxz1ScmnBWdn49qYMXalMdMy6sTnA-xkLVVA2HyrP2xFtD%5FnL6%5FyC1W5Nda7e89BSgEPyrmUJl-s%5Fm7iF-z5lYBG72fl%5FKgautR2HCwBPq4gKIMVgelOVNncdaz5dADelWyNos257afaFqMVuyIXnM-RrbYnG2j1J4RRABhrx01PvNJP1MyrqUXH4Sqkk99uIf8bq%5Fhwki9DniLoS8Fz2M%5FjA97X8AE4F%5FR0Nr3RtFqsR5Qqcl4Hs=&ref=fdaweb.com) from the CLEAR MIND Phase 2a clinical trial and [additional clinical data and imaging biomarker results](https://www.globenewswire.com/Tracker?data=ks8Hpe2dzQp3V3GuhceYlm-8wUfvAGudSWi1MfQ0YwdUUQO4rwapjnLJzRffiF0uIFqHFYZWXGCpiHIXJtls%5F8oMJMW2bw3vFWIDxB2bIw9DB56k14PHtHTRfEjD%5FSiWH4EeUqIUFoTqmwi7WE5j2tKmR7gq7kc0jgOxhuRvXGYvow4mdm7Wt1aejdhjsHqsCYDcVZcwIGaZXWYNia5E97JACYeTB6Ydo7SMyzL-0rOEStpVvB-SXOzJGhlH-yONcY6wB7yTJv%5Fy5jQOlVnZvjCouyXmXcF4lMbpmqPhGCL9mY%5F7pvmX-LQWxr7ANccXWhfz0D2SCsas-yEMcxJJq3J-cKhIF0ypnHJlrHJvEwHcpnnOF2-Dvapg18Uxm%5Fg4pDQxuzGA1NOld-elqhlI33ihWHbFoBOgjP9qRPbnxb-9NONZRcWzGh2MXjodRaRE&ref=fdaweb.com). Full study results for CLEAR MIND will be reported 7/28 at the 2024 Alzheimer’s Association International Conference.

The company says the RMAT designation is the fourth special regulatory designation received for Lomecel-B. Previously, the therapy was granted an [Orphan Drug designation](https://www.globenewswire.com/Tracker?data=uaW2oMgRMW42rj7BjOxjolA29NVS4UjBxvJ37RCdunhHnplJZBuSawp02vAvcE9GjWpRknl7QBfK0rZI7iwiMsSTwVzlFLp3nR5fg%5FyFW5DMDvauV0S%5F-PMLA0lnMIPztdwDf0E9Jwc6ua7BAyzvR8StJW0IZYtkmynDpN027GKVd5%5FZUjM4ebYIuUB7WIyunxjz4P8MAmMdYY-Amuaf52QzbsKqVlrtDi-YtzRPmOfxRkQ29G%5FXSt2MGpJYlcuo&ref=fdaweb.com), [Fast Track designation](https://www.globenewswire.com/Tracker?data=f55vAgBHmGuIpvkDDremoBrNv1hjMLujzqo-VtWMRkIcxgHXlKi11LkN7e3wVR50L89OgQdt8Yo8q5HENZ1ciUfkPv7lMjNk5k1xIDJW9mFrEQ86yaMPN8EBwm2oOgCBfH9pCow-iIp-lBv-g7sSC9uji5Mbep7TLBVtkqFwfjaGmSvPxXDk3jo9DhX4fUOkeEoBRi-%5Fs28wgzkz7oielA==&ref=fdaweb.com), and [Rare Pediatric Disease designation](https://www.globenewswire.com/Tracker?data=Nsg2c3x51Jr7jjOTpXv5MzroQfyK3qo1LonZjLMAMFdv8d3iDgO5tTQ3VTejEpTURHG4XbhEkRAzETxk7QVENWa9CbpwdMsbATzzdOtykvPPVbe7n0JyrIWVMJTcIzRH-tDPI6xJHL%5FrKq7-JTT%5Ftc7b9OSCzmNNAEZgrV7T6wtOnYzoqEQS-nyuDOUVcIapSg09RF-5eMWCQf9hxfAdgji3T-jJxMJoEWBaBOgylHkIxhWJFczTHu9RyFIxqewevwRjzfXuWVXgnHeRfg6S9Q==&ref=fdaweb.com).