NCT02444455

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

May 8, 2015

Last Update Submit

May 11, 2015

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

cellular therapyacute lung injuryacute respiratory distress snydromehuman umbilical cord mesenchymal stem cellphase 1/2 clinical studyallogeneic stem cell transplantationALIARDS

Outcome Measures

Primary Outcomes (1)

  • Safety will be determined by the assessment of major adverse events

    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 Outcomes (4)

  • 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.

  • 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

  • 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

Study Arms (1)

UCMSC group

EXPERIMENTAL

Human umbilical cord MSCs are administrated to patients by intravenous infusion

Biological: UCMSC group

Interventions

UCMSC groupBIOLOGICAL

Human umbilical cord MSCs are transplanted by intravenous infusion(5×10\^5/kg) once a day,a total of three times.

UCMSC group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Bing Liu, M.D.

    307-IVY Translational Medicine Center

    STUDY CHAIR

  • Changqing Bai, M.D.

    Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences

    STUDY DIRECTOR

  • Huiying Liu, M.D.

    Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changqing Bai, M.D.

CONTACT

+86-010-66947356baicq307@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

CN(1)