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NCT01775774 · ClinicalTrials.gov registry record · Phase 1

Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome

A Phase 1 study of Acute Respiratory Distress Syndrome, sponsored by Michael A. Matthay.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
4
Study locations

NCT01775774: Completed Phase 1 study of Acute Respiratory Distress Syndrome, sponsored by Michael A. Matthay.

NCT01775774 is a Phase 1 study of Acute Respiratory Distress Syndrome that has completed, run by Michael A. Matthay. The registered enrollment target is 9 participants, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01775774, a Phase 1 study of Acute Respiratory Distress Syndrome, has completed, sponsored by Michael A. Matthay.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
4
Study locations

Study Summary

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

Primary Outcome

Any of the following occurring within 6 h of mesenchymal stem-cell infusion: * Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following: * Norepinephrine: 10 μg per min * Phenylephrine: 100 μg per min * Dopamine: 10 μg/kg per min * Epinephrine: 0·1 μg/kg per min * Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous

Conditions Studied

Acute Respiratory Distress Syndrome

Interventions

  • BIOLOGICAL Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells

Study Locations (4)

California

  • University of California San Francisco Medical Center - San Francisco
  • Stanford University Medical Center - Stanford

Massachusetts

  • Massachusetts General Hospital - Boston

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2013-07
Est. Completion 2015-02
Phase Phase 1
Michael A. Matthay

3 total trials

What the finished NCT01775774 record still lists

NCT01775774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 367-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells is the first listed.

NCT01775774 reports a single indexed study location in California, Massachusetts, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01775774 about?

NCT01775774 is a clinical study titled "Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome". This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

What is the current status of trial NCT01775774?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-07. Estimated completion is 2015-02.

What conditions does trial NCT01775774 study?

This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome.

What interventions are being tested in trial NCT01775774?

The interventions under investigation include: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01775774?

This trial is sponsored by Michael A. Matthay, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01775774 being conducted?

This trial has 4 study locations across California, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Respiratory Distress Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01775774's enrollment target sits among peer trials

9 29th of 31 higher than 3 of 31 other Acute Respiratory Distress Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome 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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Related registry views

Source: ClinicalTrials.gov NCT01775774, the US trial registry maintained by the National Library of Medicine. NCT01775774 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.