Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Shaoxing Second Hospital

Status and phase: Unknown; Phase 1

Conditions: ARDS

Treatments: Drug: Placebo; Drug: Mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01902082

MSCs in ARDS

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ARDS diagnosed using Berlin definition
2. Eligible patients were at least 18 years of age had acute onset of ARDS.
3. Bilateral opacities in chest radiography
4. No cardiac failure
5. PaO2/FiO2 ratio < 200

Exclusion criteria

1. 72 hours after all inclusion criteria met
2. Pre-existing severe diseases of any major organs
3. Pregnancy
4. Pulmonary hypertension
5. Malignant diseases
6. HIV infections.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell arm

Experimental group

Description:

Patients received one dose of 1x 10\^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.

Treatment:

Drug: Mesenchymal stem cells

Placebo

Placebo Comparator group

Description:

Patients received one dose of normal saline.

Treatment:

Drug: Placebo