Drugs / laromestrocel
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05233774 | Dec 2021 → Sep 2023 | Alzheimer disease | Longeveron Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Longeveron Inc. | Results Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease longeveron.com ↗
Results support a clinically relevant and long-lasting anti-inflammatory mechanism of action of laromestrocel in gray and white matter of the brain, indicate potential blood biomarker correlates with clinical outcomes, and support continued clinical development of laromestrocel for Alzheimer’s disease |
| 2026-05-11 | Longeveron Inc. | Results Longeveron Announces Independent Data Monitoring Committee Positive Review and Recommendation to Complete Phase 2b Stem Cell Therapy Clinical Trial in Hypoplastic Left Heart Syndrome (HLHS) longeveron.com ↗
The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion. |
| 2026-02-25 | Longeveron Inc. | Results Longeveron® Results of Phase 2b Clinical Trial Demonstrating Stem Cell Therapy Improved Condition of Patients with Age-Related Frailty Published in Cell Stem Cell longeveron.com ↗
The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. |
| 2026-01-26 | Longeveron Inc. | Regulatory Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS) longeveron.com ↗ |
| 2025-12-01 | Longeveron Inc. | Results Longeveron New MRI Biomarker Data Linking Neuroinflammation to Clinical Outcomes in Patients with Mild Alzheimer’s Disease Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) longeveron.com ↗
Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of hippocampal volume and with clinical outcomes |
| 2025-07-08 | Longeveron Inc. | Regulatory Longeveron® Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM) longeveron.com ↗
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). |
| 2025-03-11 | Longeveron Inc. | Results Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer’s Disease longeveron.com ↗
Phase 2a results demonstrated laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease |
| 2025-02-18 | Longeveron Inc. | Regulatory Longeveron® Announces World Health Organization Approval of “laromestrocel” as International Non-proprietary Name for Stem Cell Therapy Lomecel-B™ longeveron.com ↗
Cellular therapy Lomecel-B™ has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | laromestrocel | “Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial.” PMID 40065171 ↗ Mar 2025 |
| Modality | Cell therapy | “laromestrocel, a bone-marrow-derived, allogeneic mesenchymal stem-cell therapy” PMID 40065171 ↗ Mar 2025 |
| Route | Other | “Participants across ten centers in the United States were randomly assigned 1:1:1:1 to four infusion groups” PMID 40065171 ↗ Mar 2025 |