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Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome

S

Shaoxing Second Hospital

Status and phase

Unknown
Phase 1

Conditions

ARDS

Treatments

Drug: Placebo
Drug: Mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01902082
MSCs in ARDS

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell arm
Experimental group
Description:
Patients received one dose of 1x 10\^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment.
Treatment:
Drug: Mesenchymal stem cells
Placebo
Placebo Comparator group
Description:
Patients received one dose of normal saline.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Guoping Zheng, MD; Jianguo Xu, PhD

Data sourced from clinicaltrials.gov

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