Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

July 14, 2013 updated by: Shaoxing Second Hospital

Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing Second Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianguo Xu, PhD
        • Sub-Investigator:
          • Guoping Zheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ARDS diagnosed using Berlin definition
  2. Eligible patients were at least 18 years of age had acute onset of ARDS.
  3. Bilateral opacities in chest radiography
  4. No cardiac failure
  5. PaO2/FiO2 ratio < 200

Exclusion Criteria:

  1. 72 hours after all inclusion criteria met
  2. Pre-existing severe diseases of any major organs
  3. Pregnancy
  4. Pulmonary hypertension
  5. Malignant diseases
  6. HIV infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal stem cell arm
Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.
Drug: Mesenchymal stem cells
Placebo Comparator: Placebo
Patients received one dose of normal saline.
Drug: Placebo
Other Names:
  • Intravenous saline infusion will be designated as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the adverse events between mesenchymal stem cell treatment and placebo groups
Time Frame: From day 0 at the start of treatment to day 28.
From day 0 at the start of treatment to day 28.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital indices by treatment group
Time Frame: From admission to discharge
Days in hospital ICU free days at day 28 Ventilator free days at day 28
From admission to discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokines
Time Frame: Day 0 to day 7
IL-6, IL-8, SP-D, TNF-alpha
Day 0 to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaoxing Second Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

July 14, 2013

First Submitted That Met QC Criteria

July 14, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 14, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCs in ARDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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