Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury

Phase 1

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

• Registration Number: NCT02444455
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.

Detailed Description

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.

Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.

Clinical results will be analyzed after completion of 14 days of followup.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-11
• Last Update Submitted: 2015-05-11
• Study First Posted: 2015-05-14
• Last Update Posted: 2015-05-14
• Primary Completion: 2017-03
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Signed informed consent
• Age between 35 and 70 y
• Acute onset within 7 days.
• Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg
• Bilateral infiltrates on chest radiography
• No cardiac failure

Exclusion Criteria

• Declined to sign informed consent
• Socially and mentally disabilities
• Malignant diseases
• Combined with severe infectious diseases
• Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
• Pregnant or perinatal women
• Severe diseases of any major organs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety will be determined by the assessment of major adverse events	From day 0 at the start of treatment to day 14.	Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.

Secondary Outcome Measures

Name	Time	Method
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8	6 hours post-infusion, and days 1, 2, and 3
The efficacy of UC-MSC treatment was measured by arterial blood gas analysis	Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6	6 hours post-infusion, and days 1, 2, and 3
Quantify pulmonary respiratory function measured by chest computerized tomography	Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.

Trial Locations

Locations (1)

Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China