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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell arm | Experimental | Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment. |
|
| Placebo | Placebo Comparator | Patients received one dose of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the adverse events between mesenchymal stem cell treatment and placebo groups | From day 0 at the start of treatment to day 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital indices by treatment group | Days in hospital ICU free days at day 28 Ventilator free days at day 28 | From admission to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| cytokines | IL-6, IL-8, SP-D, TNF-alpha | Day 0 to day 7 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoping Zheng, MD | Contact | 13385851678 | zgp28037@163.com | |
| Jianguo Xu, PhD | Contact | 575-88053995 | jxu6325@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoxing Second Hospital | Recruiting | Shaoxing | Zhejiang | 312000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24708472 | Derived | 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. |
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