Approval Probability
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Also known as Longeveron Mesenchymal Stem Cells (LMSCs)
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 is an investigational cell therapy being studied for Aging Frailty and Alzheimer's Disease. Clinical trials have enrolled older adults with frailty and patients with Alzheimer's Disease in the United States. It is not an approved treatment for either condition.
Longeveron Mesenchymal Stem Cells is developed by Longeveron Inc., a clinical-stage biotechnology company that trades under the ticker LGVN. Longeveron is the sponsor of the clinical trials evaluating this cell therapy in Aging Frailty and Alzheimer's Disease.
Longeveron Mesenchymal Stem Cells is in Phase 2 development. The most advanced study is a completed Phase IIb trial in Aging Frailty, and additional completed Phase 1 trials have evaluated the therapy in Aging Frailty and Alzheimer's Disease. It remains investigational and has not been approved by the FDA.
Three completed trials have evaluated Longeveron Mesenchymal Stem Cells: NCT03169231, a Phase IIb trial in Aging Frailty with 150 participants; NCT02982915, a Phase 1 trial in Aging Frailty with 62 participants; and NCT02600130, a Phase 1 trial in Alzheimer's Disease with 33 participants. All were conducted in the United States.
Yes. Longeveron Mesenchymal Stem Cells is also referred to as Longeveron Mesenchymal Stem Cells (LMSCs). The abbreviation LMSCs is shorthand for the same investigational cell therapy developed by Longeveron Inc. for Aging Frailty and Alzheimer's Disease.
The Longeveron Mesenchymal Stem Cells trials were randomized, double-blind, and controlled studies. The Phase IIb Aging Frailty trial, NCT03169231, enrolled 150 participants aged 70 years and older, while the Alzheimer's Disease trial, NCT02600130, enrolled 33 participants aged 50 years and older.