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NCT02065245 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Longeveron.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT02065245: Completed Phase 1 study, sponsored by Longeveron.

NCT02065245 is a Phase 1 study that has completed, run by Longeveron. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02065245, a Phase 1 study, has completed, sponsored by Longeveron.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

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

Primary Outcome

Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hemato

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)
  • BIOLOGICAL Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2014-03-03
Est. Completion 2020-10-02
Phase Phase 1
Longeveron

7 total trials

What the finished NCT02065245 record still lists

NCT02065245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02065245 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02065245 about?

NCT02065245 is a clinical study titled "AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery". The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

What is the current status of trial NCT02065245?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2014-03-03. Estimated completion is 2020-10-02.

What interventions are being tested in trial NCT02065245?

The interventions under investigation include: Placebo (BIOLOGICAL), Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) (BIOLOGICAL), Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) (BIOLOGICAL).

Who is sponsoring clinical trial NCT02065245?

This trial is sponsored by Longeveron, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02065245's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02065245, the US trial registry maintained by the National Library of Medicine. NCT02065245 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.