Lomecel-B Effects on Alzheimer's Disease

Summary

Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In our Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns, and showed potential to improve clinical assessments. Mechanistically, Lomecel-B treated subjects had higher serum concentrations of pro-vascular and anti-inflammatory biomarkers relative to placebo. This trial builds upon those preliminary Phase 1 results, and is designed to evaluate the safety profile of multiple infusions of Lomecel-B, and to investigate provisional efficacy of single dosing versus multiple dosing of Lomecel-B on cognitive function and biomarkers in AD subjects.

Timeline

Start

2021-12-28

Primary completion

2023-09-29

Completion

2023-09-29

Outcome

Met primary endpoint

paper The study met its primary end point of safety; PMID 40065171 ↗

release “In the completed Phase 2a clinical trial (CLEAR MIND), laromestrocel treated patients showed an overall slowing/prevention of disease worsening compared to placebo.” longeveron.com ↗

release “The clinical trial achieved its primary safety and secondary efficacy endpoints” longeveron.com ↗

Publications

• Rash BG, Ramdas KN, Agafonova N, Naioti E, McClain-Moss L, Zainul Z, Varnado B, Peterson K, Brown M, Leal T, Kopcho S, Carballosa R, Patel P, Brody M, Herskowitz B, Fuquay A, Rodriguez S, Jacobson AF, Leon R, Pfeffer M, Schwartzbard JB, Botbyl J, Oliva AA Jr, Hare JM. Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial. Nat Med. 2025 Apr;31(4):1257-1266. doi: 10.1038/s41591-025-03559-0. Epub 2025 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	laromestrocel	Cell therapy	2.5e+07 cells	Other
Subject	laromestrocel	Cell therapy	1e+08 cells	Other

Indications