NCT01902082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1.6 years

First QC Date

July 14, 2013

Last Update Submit

July 14, 2013

Conditions

ARDS

Keywords

ARDSmesenchymal stem cellsSafetyCytokines

Outcome Measures

Primary Outcomes (1)

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

    From day 0 at the start of treatment to day 28.

Secondary Outcomes (1)

  • Hospital indices by treatment group

    From admission to discharge

Other Outcomes (1)

  • cytokines

    Day 0 to day 7

Study Arms (2)

Mesenchymal stem cell arm

EXPERIMENTAL

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

Drug: Mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

Patients received one dose of normal saline.

Drug: Placebo

Interventions

Mesenchymal stem cellsDRUG
Mesenchymal stem cell arm
PlaceboDRUG
Also known as: Intravenous saline infusion will be designated as placebo.
Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pre-existing severe diseases of any major organs
  • Pregnancy
  • Pulmonary hypertension
  • Malignant diseases
  • HIV infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaoxing Second Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Related Publications (1)

  • Zheng G, Huang L, Tong H, Shu Q, Hu Y, Ge M, Deng K, Zhang L, Zou B, Cheng B, Xu J. Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study. Respir Res. 2014 Apr 4;15(1):39. doi: 10.1186/1465-9921-15-39.

    PMID: 24708472DERIVED

Central Study Contacts

Guoping Zheng, MD

CONTACT

13385851678zgp28037@163.com

Jianguo Xu, PhD

CONTACT

575-88053995jxu6325@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2013

First Posted

July 18, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

CN(1)