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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10\^5/kg) once a day,a total of three times.
Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, China
RECRUITINGSafety 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.
Time frame: From day 0 at the start of treatment to day 14.
Quantify pulmonary respiratory function measured by chest computerized tomography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 hours post-infusion, and days 1, 2, and 3
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