Trials / Completed
CompletedNCT03169231
Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty
A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogenic Human Mesenchymal Stem Cells Infusion in Patients With Aging Frailty
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Longeveron Inc. · Industry
- Sex
- All
- Age
- 70 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study.
Detailed description
The objectives of this study are to assess safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) compared to placebo on 1) functional mobility and exercise tolerance, 2) patient-reported physical function, and 3) the inflammatory cytokine biomarker tumor necrosis factor (TNF-alpha).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Longeveron Mesenchymal Stem Cells (LMSCs) | Intravenously delivered |
| OTHER | Placebo | Intravenously delivered |
Timeline
- Start date
- 2017-07-06
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2017-05-30
- Last updated
- 2022-03-07
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03169231. Inclusion in this directory is not an endorsement.