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Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
ARDS Drug: Mesenchymal stem cells Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Study Start Date : November 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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Arms and Interventions
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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 Name: Intravenous saline infusion will be designated as placebo.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. cytokines [ Time Frame: Day 0 to day 7 ]
    IL-6, IL-8, SP-D, TNF-alpha


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902082


Contacts
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Contact: Guoping Zheng, MD 13385851678 zgp28037@163.com
Contact: Jianguo Xu, PhD 575-88053995 jxu6325@yahoo.com

Locations
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China, Zhejiang
Shaoxing Second Hospital Recruiting
Shaoxing, Zhejiang, China, 312000
Contact: Guoping Zheng, MD    13385851678    zgp28037@163.com   
Contact: Jianguo Xu, PhD    575-88053995    jxu6325@yahoo.com   
Principal Investigator: Jianguo Xu, PhD         
Sub-Investigator: Guoping Zheng, MD         
Sponsors and Collaborators
Shaoxing Second Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shaoxing Second Hospital
ClinicalTrials.gov Identifier: NCT01902082    
Other Study ID Numbers: MSCs in ARDS
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013
Keywords provided by Shaoxing Second Hospital:
ARDS
mesenchymal stem cells
Safety
Cytokines
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury