Trials / Completed
CompletedNCT02982915
Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty
Effects of Intravenous Delivery of Lomecel-B (Formerly Allogenic Longeveron Human Mesenchymal Stem Cells (LMSCs)) on VaccinE-Specific Antibody Responses in Subjects With Aging Frailty
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Longeveron Inc. · Industry
- Sex
- All
- Age
- 65 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and efficacy of Lomecel-B for improving vaccine immune response.
Detailed description
A pilot phase will consist of a 3 subject safety run-in, followed by 20 subject randomized phase to evaluate influenza vaccine response at 1 week and 4 weeks post infusion of Lomecel-B (Formerly LMSCs). This will be followed by a double-blinded, randomized, placebo-controlled phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Longeveron Mesenchymal Stem Cells (LMSCs) | Intravenously delivered |
| BIOLOGICAL | Fluzone High Dose Vaccine | Intramuscular injection |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2021-09-01
- Completion
- 2022-09-01
- First posted
- 2016-12-06
- Last updated
- 2022-11-04
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02982915. Inclusion in this directory is not an endorsement.