Acute Lung Injury, Acute Respiratory Distress Syndrome
Conditions
Keywords
cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation, ALI, ARDS
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALUCMSC group
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10\^5/kg) once a day,a total of three times.
Sponsors
Ivy Institute of Stem Cells Co. Ltd
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age between 35 and 70 y * Acute onset within 7 days. * Oxygenation index:200\<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2\>35mmHg * Bilateral infiltrates on chest radiography * No cardiac failure
Exclusion criteria
* Declined to sign informed consent * Socially and mentally disabilities * Malignant diseases * Combined with severe infectious diseases * Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening * Pregnant or perinatal women * Severe diseases of any major organs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be determined by the assessment of major adverse events | From day 0 at the start of treatment to day 14. | 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. |
Secondary
| Measure | 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 | 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 |
Countries
China
Contacts
Primary ContactChangqing Bai, M.D.
Outcome results
None listed