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| Name | Class |
|---|---|
| Ivy Institute of Stem Cells Co. Ltd | INDUSTRY |
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Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind, controlled prospective study.
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury,randomized, single blind, controlled prospective study.
Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.
Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.
The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.
Clinical results will be analyzed after completion of 2 months of followup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by intravenous injection |
|
| Control group(Normal saline) | Other | Patients will receive normal saline at the same time points as that in experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSC group | Biological | Human umbilical cord MSCs are transplanted by intravenous injection(5×10^5/kg) ，once a day,a total of three times. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety will be determined by the assessment of major adverse events. | Safety will be determined by the assessment of major adverse events defined as trial-related death,required hospitalization or prolonged hospitalization time, persistent or significant loss of organ function，other serious adverse events. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of UC-MSC treatment was measured clinical evaluation. | The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before. | 2 months |
| The efficacy of UC-MSC treatment was measured by chest computerized tomography. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zewu Qiu, M.D. | Contact | +86-010-66947376 | qiuzw828@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Liu, M.D. | 307-IVY Translational Medicine Center | Study Chair |
| Zewu Qiu, M.D. | Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences | Recruiting | Beijing | 100071 | China |
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| ID | Term |
|---|---|
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
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| Control group(Normal saline) | Other | Normal saline in same volume as MSCs are transplanted to patients. |
|
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 2 months, as measured by chest computerized tomography(CT). |
| 2 months |
| The efficacy of UC-MSC treatment was monitored by pulmonary function. | The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index). | 2 months |
| The efficacy of UC-MSC treatment was measured by lab Indicators. | The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein). | 2 months |
| Haochun Wang, M.D. | Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Xiaobo Peng, M.D. | Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Chunyan Wang, M.D. | Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |