Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

ARDS Clinical Trial

Official title:

Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01902082
• Other study ID #: MSCs in ARDS
• Status: Recruiting
• Phase: Phase 1
• First received: July 14, 2013
• Last updated: July 14, 2013
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2013
• Source: Shaoxing Second Hospital
• Contact: Guoping Zheng, MD
• Phone: 13385851678
• Email: zgp28037[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Mesenchymal stem cells

• Placebo

Locations

Country	Name	City	State
China	Shaoxing Second Hospital	Shaoxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shaoxing Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cytokines	IL-6, IL-8, SP-D, TNF-alpha	Day 0 to day 7	No
Primary	Compare the adverse events between mesenchymal stem cell treatment and placebo groups		From day 0 at the start of treatment to day 28.	Yes
Secondary	Hospital indices by treatment group	Days in hospital ICU free days at day 28 Ventilator free days at day 28	From admission to discharge	No