NCT02444858

Brief Summary

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind, 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
40

participants targeted

Target at P50-P75 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
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

May 12, 2015

Last Update Submit

May 12, 2015

Conditions

Paraquat PoisoningLung Injury

Keywords

paraquat poisoninglung injurystem cell therapyhuman umbilical cord mesenchymal stem cellphase 1/2 clinical studyallogeneic stem cell transplantation

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 trial-related death,required hospitalization or prolonged hospitalization time, persistent or significant loss of organ function，other serious adverse events.

    2 months

Secondary Outcomes (4)

  • The efficacy of UC-MSC treatment was measured clinical evaluation.

    2 months

  • The efficacy of UC-MSC treatment was measured by chest computerized tomography.

    2 months

  • The efficacy of UC-MSC treatment was monitored by pulmonary function.

    2 months

  • The efficacy of UC-MSC treatment was measured by lab Indicators.

    2 months

Study Arms (2)

UCMSC group

EXPERIMENTAL

Human umbilical cord MSCs are administrated to patients by intravenous injection

Biological: UCMSC group

Control group(Normal saline)

OTHER

Patients will receive normal saline at the same time points as that in experimental group.

Other: Control group(Normal saline)

Interventions

UCMSC groupBIOLOGICAL

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

UCMSC group
Control group(Normal saline)OTHER

Normal saline in same volume as MSCs are transplanted to patients.

Control group(Normal saline)

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 15 and 60 y(including 15y)
  • A history of ingestion paraquat, and hospitalization within 96 hours after paraquat poisoning
  • No previous organic disease history of serious heart, liver, kidney and lung, etc;
  • Patients with moderate poisoning (oral dose of 20-40mg of PQ ion/kg of body weight)
  • Patient or his legal agent signed informed consent voluntarily
  • Capable of good communication with researchers and follow the entire test requirements

You may not qualify if:

  • Refused to sign informed consent
  • Elderly high-risk patients
  • Socially and mentally disabilities
  • Hepatitis B, hepatitis C, HIV and tuberculosis patients
  • Pregnant or perinatal women
  • Severe organ failure patients
  • Patients participated in clinical trials of other drugs within 3 months
  • Other circumstances not suitable to the trial(mixed toxicants poisoning)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Bing Liu, M.D.

    307-IVY Translational Medicine Center

    STUDY CHAIR

  • Zewu Qiu, M.D.

    Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences

    STUDY DIRECTOR

  • Haochun Wang, M.D.

    Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Xiaobo Peng, M.D.

    Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Chunyan Wang, M.D.

    Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zewu Qiu, M.D.

CONTACT

+86-010-66947376qiuzw828@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 15, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

May 15, 2015

Record last verified: 2015-04

Locations

CN(1)