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

NCT02065245 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-07-14

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Longeveron Inc.

    lead INDUSTRY

Principal Investigators

  • Joshua M Hare, MD · ISCI / University of Miami Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-03
Primary Completion
2019-10-02
Completion
2020-10-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065245 on ClinicalTrials.gov