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Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

Primary Purpose

ARDS

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mesenchymal stem cells
Placebo
Sponsored by
Shaoxing Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS focused on measuring ARDS, mesenchymal stem cells, Safety, Cytokines

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shaoxing Second HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesenchymal stem cell arm

Placebo

Arm Description

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

Patients received one dose of normal saline.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital indices by treatment group
Days in hospital ICU free days at day 28 Ventilator free days at day 28

Full Information

First Posted
July 14, 2013
Last Updated
July 14, 2013
Sponsor
Shaoxing Second Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01902082
Brief Title
Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Official Title
Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaoxing Second Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
Keywords
ARDS, mesenchymal stem cells, Safety, Cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell arm
Arm Type
Experimental
Arm Description
Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received one dose of normal saline.
Intervention Type
Drug
Intervention Name(s)
Mesenchymal stem cells
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Intravenous saline infusion will be designated as placebo.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Hospital indices by treatment group
Description
Days in hospital ICU free days at day 28 Ventilator free days at day 28
Time Frame
From admission to discharge
Other Pre-specified Outcome Measures:
Title
cytokines
Description
IL-6, IL-8, SP-D, TNF-alpha
Time Frame
Day 0 to day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 72 hours after all inclusion criteria met Pre-existing severe diseases of any major organs Pregnancy Pulmonary hypertension Malignant diseases HIV infections.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoping Zheng, MD
Phone
13385851678
Email
zgp28037@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianguo Xu, PhD
Phone
575-88053995
Email
jxu6325@yahoo.com
Facility Information:
Facility Name
Shaoxing Second Hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Zheng, MD
Phone
13385851678
Email
zgp28037@163.com
First Name & Middle Initial & Last Name & Degree
Jianguo Xu, PhD
Phone
575-88053995
Email
jxu6325@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jianguo Xu, PhD
First Name & Middle Initial & Last Name & Degree
Guoping Zheng, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24708472
Citation
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.
Results Reference
derived

Learn more about this trial

Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

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