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Status unknownNCT01902082Updated Jul 18, 2013

Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

A Phase 1 interventional study of Mesenchymal stem cells and Placebo in ARDS, sponsored by Shaoxing Second Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Shaoxing Second Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • ARDS

Keywords

  • ARDS
  • mesenchymal stem cells
  • Safety
  • Cytokines
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

This is the only study on the registry with Shaoxing Second Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Mesenchymal stem cell arm

    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 comparator
    Placebo

    Patients received one dose of normal saline.

    Drug: Placebo

Interventions

  • DrugMesenchymal stem cells
  • DrugPlacebo

    Also known as: Intravenous saline infusion will be designated as placebo.

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What researchers measure

Primary outcomes

  1. 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

  1. 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

Other outcomes

  1. cytokines

    IL-6, IL-8, SP-D, TNF-alpha

    Time frame: Day 0 to day 7

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Study locations

1 of 1 sites recruiting
  • Shaoxing Second Hospital
    Shaoxing, Zhejiang 312000, China
    • Guoping Zheng, MD · Contact · zgp28037@163.com · 13385851678
    • Jianguo Xu, PhD · Contact · jxu6325@yahoo.com · 575-88053995
    • Jianguo Xu, PhD · Principal investigator
    • Guoping Zheng, MD · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 24708472 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01902082
Lead sponsor
Shaoxing Second Hospital
Responsible party
Sponsor
First posted
Jul 18, 2013
Start date
Nov 2012
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Jul 18, 2013

Study contacts

Guoping Zheng, MD
Contact
zgp28037@163.com
13385851678
Jianguo Xu, PhD
Contact
jxu6325@yahoo.com
575-88053995

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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