NCT02065245

AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery

A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Longeveron Inc. · Industry
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

Conditions

• Frailty

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)	Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
BIOLOGICAL	Placebo	Placebo administered by peripheral intravenous infusion.
BIOLOGICAL	Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)	Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.

Timeline

• Start date: 2014-03-03
• Primary completion: 2019-10-02
• Completion: 2020-10-02
• First posted: 2014-02-17
• Last updated: 2021-07-14
• Results posted: 2021-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study