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
|Condition or disease||Intervention/treatment||Phase|
|ARDS||Drug: Mesenchymal stem cells Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
Other Name: Intravenous saline infusion will be designated as placebo.
- 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. ]
- 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
- cytokines [ Time Frame: Day 0 to day 7 ]IL-6, IL-8, SP-D, TNF-alpha
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
|Contact: Guoping Zheng, MDfirstname.lastname@example.org|
|Contact: Jianguo Xu, PhDemail@example.com|
|Shaoxing Second Hospital||Recruiting|
|Shaoxing, Zhejiang, China, 312000|
|Contact: Guoping Zheng, MD 13385851678 firstname.lastname@example.org|
|Contact: Jianguo Xu, PhD 575-88053995 email@example.com|
|Principal Investigator: Jianguo Xu, PhD|
|Sub-Investigator: Guoping Zheng, MD|