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Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902082
Recruitment Status : Unknown
Verified July 2013 by Shaoxing Second Hospital.
Recruitment status was:  Recruiting
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Shaoxing Second Hospital

Tracking Information
First Submitted Date  ICMJE July 14, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date July 18, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2013)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 14, 2013)
cytokines [ Time Frame: Day 0 to day 7 ]
IL-6, IL-8, SP-D, TNF-alpha
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Official Title  ICMJE Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE ARDS
Intervention  ICMJE
  • Drug: Mesenchymal stem cells
  • Drug: Placebo
    Other Name: Intravenous saline infusion will be designated as placebo.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Mesenchymal stem cells
  • Placebo Comparator: Placebo
    Patients received one dose of normal saline.
    Intervention: Drug: Placebo
Publications * Zheng G, Huang L, Tong H, Shu Q, Hu Y, Ge M, Deng K, Zhang L, Zou B, Cheng B, Xu J. Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study. Respir Res. 2014 Apr 4;15:39. doi: 10.1186/1465-9921-15-39.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902082
Other Study ID Numbers  ICMJE MSCs in ARDS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaoxing Second Hospital
Study Sponsor  ICMJE Shaoxing Second Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shaoxing Second Hospital
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP