Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI)

May 11, 2015 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Changqing Bai, M.D.
  • Phone Number: +86-010-66947356
  • Email: baicq307@163.com

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous infusion
Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be determined by the assessment of major adverse events
Time Frame: 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.
From day 0 at the start of treatment to day 14.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

Ivy Institute of Stem Cells Co. Ltd

Investigators

  • Study Director: Changqing Bai, M.D., Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
  • Principal Investigator: Huiying Liu, M.D., Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-IVY-SC-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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