5 completed, 2 unknown, 1 active not recruiting, 1 terminated. 7 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 4, Active not recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 1 | 6 | Completed 3, Unknown 2, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial Peripheral Intravenous (IV) infusion of LMSCs - Metabolic Disease, Endothelial Dysfunction | Phase 2 | Withdrawn | Longeveron Inc. | 2023-12-01 | 2023-02-16 | |
| Lomecel-B Effects on Alzheimer's Disease Allogeneic MSC, Placebo - Mild Alzheimer's Disease | Phase 2 | Completed | Longeveron Inc. | 50 | 2021-12-28 | 2024-02-20 |
| Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. Lomecel-B medicinal signaling cells - Hypoplastic Left Heart Syndrome | Phase 2 | Active not recruiting | Longeveron Inc. | 40 | 2021-06-25 | 2025-06-25 |
| Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) Longeveron Mesenchymal Stem Cells (LMSCs), Placebo - ARDS, Human, Covid19 | Phase 1 | Unknown | Longeveron Inc. | 70 | 2020-07-24 | 2024-02-20 |
| Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) Longeveron Mesenchymal Stem Cells - HLHS | Phase 1 / Phase 2 | Unknown | Longeveron Inc. | 10 | 2018-02-21 | 2023-10-04 |
| Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty Longeveron Mesenchymal Stem Cells (LMSCs), Placebo - Aging Frailty | Phase 2 | Completed | Longeveron Inc. | 150 | 2017-07-06 | 2022-03-07 |
| Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty Longeveron Mesenchymal Stem Cells (LMSCs), Fluzone High Dose Vaccine - Aging Frailty | Phase 1 / Phase 2 | Completed | Longeveron Inc. | 62 | 2016-11-01 | 2022-11-04 |
| Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease Longeveron Mesenchymal Stem Cells, Placebo - Alzheimer's Disease | Phase 1 | Completed | Longeveron Inc. | 33 | 2016-10-10 | 2021-12-14 |
| Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome Allo-hMSCs, Placebo - Hypoplastic Left Heart Syndrome | Phase 1 | Terminated | Longeveron Inc. | 5 | 2015-04-01 | 2021-07-19 |
| AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs), Placebo, Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) - Frailty | Phase 1 / Phase 2 | Completed | Longeveron Inc. | 65 | 2014-03-03 | 2021-07-14 |
Hypoplastic Left Heart Syndrome (2) · Alzheimer Disease (1) · COVID-19 (1) · Frailty (1) · Metabolic Diseases (1) · Respiratory Distress Syndrome (1)
Biological Products (1) · Influenza Vaccines (1) · Penicillins (1) · Vaccines (1)
United States (9)
Anthony Oliva, MD (1) · Anthony Oliva, PhD (1) · Joshua M Hare, MD (1) · Stu Berger, MD (1)
PMID 36950450, PMID 40065171, PMID 41747733
7UG3HL148318-02 (1), U24HL148316 (1)