Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ivy Institute of Stem Cells Co. Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.
Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.
Clinical results will be analyzed after completion of 14 days of followup.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSC group | Biological | Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times. |
|
| 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 death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion. | From day 0 at the start of treatment to day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify pulmonary respiratory function measured by chest computerized tomography | Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. | |
| The efficacy of UC-MSC treatment was measured by arterial blood gas analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changqing Bai, M.D. | Contact | +86-010-66947356 | baicq307@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Liu, M.D. | 307-IVY Translational Medicine Center | Study Chair |
| Changqing Bai, M.D. | Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences | Recruiting | Beijing | 100071 | China |
Not provided
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. |
| The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6 | 6 hours post-infusion, and days 1, 2, and 3 |
| The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8 | 6 hours post-infusion, and days 1, 2, and 3 |
| Huiying Liu, M.D. | Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |