Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Phase 1UnknownNCT01902082

Shaoxing Second Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

ARDS

Interventions

Mesenchymal stem cellsDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaoxing Second Hospital

Shaoxing, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Compare the adverse events between mesenchymal stem cell treatment and placebo groups

Time frame: From day 0 at the start of treatment to day 28.

Secondary Outcomes

Hospital indices by treatment group

Days in hospital ICU free days at day 28 Ventilator free days at day 28

Time frame: From admission to discharge

Central Contacts

Guoping Zheng, MD

CONTACT

13385851678 zgp28037@163.com

Jianguo Xu, PhD

CONTACT

575-88053995 jxu6325@yahoo.com

Data from ClinicalTrials.gov

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