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

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.
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Drug: Mesenchymal stem cells |
Placebo Comparator: Placebo
Patients received one dose of normal saline.
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Drug: Placebo
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

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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 |
Inclusion Criteria:
- ARDS diagnosed using Berlin definition
- Eligible patients were at least 18 years of age had acute onset of ARDS.
- Bilateral opacities in chest radiography
- No cardiac failure
- PaO2/FiO2 ratio < 200
Exclusion Criteria:
- 72 hours after all inclusion criteria met
- Pre-existing severe diseases of any major organs
- Pregnancy
- Pulmonary hypertension
- Malignant diseases
- HIV infections.

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, MD | 13385851678 | zgp28037@163.com | |
Contact: Jianguo Xu, PhD | 575-88053995 | jxu6325@yahoo.com |
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 |
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 |
ARDS mesenchymal stem cells Safety Cytokines |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |