Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Longeveron Mesenchymal Stem Cells · 3 trials · 2 indications
Change from baseline in 6MWT compared to placebo at 180 days post-infusion
* Is life-threatening (e.g., stroke or non-fatal pulmonary embolism). * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Results in death * Results in other clinically significant untoward laboratory test result(s) or medical condition(s), determined per Investigator's judgment.
Measurements of validated hemagglutination inhibition (HAI) assays at follow up visits.
Incidence of any treatment-emergent serious adverse event (TE-SAE), defined as one or more of the following untoward medical occurrences happening within the first 30 days after infusion. * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Results in death. * Leads to other clinically significant untoward laboratory test result(s) or medical condition(s), determined per Investigator's judgement (e.g., new clinically asymptomatic brain microhemorrhages).
| Arm | Type | Description |
|---|---|---|
| Study Group A | EXPERIMENTAL | Single peripheral IV infusion of 25 million Longeveron Mesenchymal Stem Cells (LMSCs) |
| Study Group B | EXPERIMENTAL | Single peripheral IV infusion of 50 million Longeveron Mesenchymal Stem Cells (LMSCs) |
| Study Group C | EXPERIMENTAL | Single peripheral IV infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs) |
| Study Group D | EXPERIMENTAL | Single peripheral IV infusion of 200 million Longeveron Mesenchymal Stem Cells (LMSCs) |
| Study Group E | PLACEBO_COMPARATOR | Single peripheral IV infusion of placebo. |
| Pilot Phase- Cohort A | EXPERIMENTAL | Single dose of 20 million Longeveron Mesenchymal Stem Cells (LMSCs) will be delivered followed by vaccination with Fluzone High-Dose at 1 week post-infusion. |
| Pilot Phase Cohort B & C | EXPERIMENTAL | Single dose of 100 million Longeveron Mesenchymal Stem Cells (LMSCs) followed by vaccination with Fluzone High-Dose at either 1 week (Cohort B) or 4 weeks (Cohort C) post infusion. |
| Double-Blind,Randomized,Placebo Phase | EXPERIMENTAL | 2 cohorts to receive a single infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs) (Cohort A: 30 subjects) or placebo (Cohort B:30 subjects) followed by vaccination with Fluzone High-Dose. |
| Cohort 1 | EXPERIMENTAL | Cohort 1 (10 subjects) Target dose 20 million Longeveron Mesenchymal Stem Cells (LMSCs) via peripheral intravenous infusion. |
| Cohort 2 | EXPERIMENTAL | Cohort 2 (10 subjects) Target dose 100 million Longeveron Mesenchymal Stem Cells (LMSCs)via peripheral intravenous infusion. |
| Cohort 3 | PLACEBO_COMPARATOR | Cohort 3 (5 subjects) Placebo (Plasmalyte A and 1% human serum albumin (HSA)) via peripheral intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| Longeveron Mesenchymal Stem Cells (LMSCs) | BIOLOGICAL | Intravenously delivered |
| Placebo | OTHER | Intravenously delivered |
| Fluzone High Dose Vaccine | BIOLOGICAL | Intramuscular injection |
| Longeveron Mesenchymal Stem Cells | BIOLOGICAL | via peripheral intravenous infusion |
Inclusion Criteria: 1. Be willing and able to provide written informed consent and comply with all procedures required by the Protocol. 2. Be \>70 and \< 85 years of age at the time of signing the Informed Consent Form. 3. Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale scor...
Longeveron Mesenchymal Stem Cells, also known as Lomecel-B, is an investigational cell therapy being studied for aging frailty and Alzheimer's disease. It is in Phase 2 clinical development for aging frailty and has completed early-phase trials for both conditions.
Longeveron Mesenchymal Stem Cells is a mesenchymal stem cell therapy, meaning it uses stem cells that can differentiate into various cell types and modulate immune responses. Its mechanism involves the regenerative and anti-inflammatory properties of these cells, though specific molecular targets are not detailed.
Longeveron Mesenchymal Stem Cells is developed by Longeveron Inc., a biopharmaceutical company publicly traded under the ticker LGVN. The company is conducting clinical trials to evaluate the therapy for aging frailty and Alzheimer's disease.
Longeveron Mesenchymal Stem Cells is in Phase 2 clinical development, specifically for aging frailty. It has completed Phase 1 trials for both aging frailty and Alzheimer's disease, and a Phase 2b trial for aging frailty has also been completed.
Longeveron Mesenchymal Stem Cells has completed three clinical trials: NCT02600130 for Alzheimer's disease, NCT02982915 for aging frailty, and NCT03169231, a Phase 2b trial for aging frailty. All trials were conducted in the United States and are now completed.
Yes, Longeveron Mesenchymal Stem Cells is also known as Lomecel-B. The clinical trials for this therapy, including those for Alzheimer's disease and aging frailty, use the name Lomecel-B to refer to the investigational stem cell treatment.