Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Phase 1

• Conditions: ARDS
• Interventions: Drug: Mesenchymal stem cells; Drug: Placebo

• Registration Number: NCT01902082
• Lead Sponsor: Shaoxing Second Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-07
• Study First Submitted: 2013-07-14
• Study First Submitted QC: 2013-07-14
• Last Update Submitted: 2013-07-14
• Study First Posted: 2013-07-18
• Last Update Posted: 2013-07-18
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell arm	Mesenchymal stem cells	Patients received one dose of 1x 10\^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.
Placebo	Placebo	Patients received one dose of normal saline.

Primary Outcome Measures

Name	Time	Method
Compare the adverse events between mesenchymal stem cell treatment and placebo groups	From day 0 at the start of treatment to day 28.

Secondary Outcome Measures

Name	Time	Method
Hospital indices by treatment group	From admission to discharge	Days in hospital ICU free days at day 28 Ventilator free days at day 28

Trial Locations

Locations (1)

Shaoxing Second Hospital; 🇨🇳 Shaoxing, Zhejiang, China