Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03169231 | Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty | PHASE2 | COMPLETED | 150 | — | — | Jul 6, 2017 | Sep 30, 2021 | Mar 7, 2022 | 7 | United States |
| NCT02982915 | Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty | PHASE1 | COMPLETED | 62 | — | — | Nov 1, 2016 | Sep 1, 2022 | Nov 4, 2022 | 6 | United States |
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.
| 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. |
| Name | Type | Description |
|---|---|---|
| Longeveron Mesenchymal Stem Cells (LMSCs) | BIOLOGICAL | Intravenously delivered |
| Placebo | OTHER | Intravenously delivered |
| Fluzone High Dose Vaccine | BIOLOGICAL | Intramuscular injection |
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...