Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury (UCMSC-PQLI)

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury

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.

Study Overview

Detailed Description

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.

Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.

Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.

The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.

Clinical results will be analyzed after completion of 2 months of followup.

Study Type

Interventional

Enrollment (Anticipated)

40

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

Study Locations

      • Beijing, China, 100071
        • Recruiting
        • Department of poisoning and treatment,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

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group(Normal saline)
Patients will receive normal saline at the same time points as that in experimental group.
Normal saline in same volume as MSCs are transplanted to patients.
Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous injection
Human umbilical cord MSCs are transplanted by intravenous injection(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: 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of UC-MSC treatment was measured clinical evaluation.
Time Frame: 2 months
The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before.
2 months
The efficacy of UC-MSC treatment was measured by chest computerized tomography.
Time Frame: 2 months
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 2 months, as measured by chest computerized tomography(CT).
2 months
The efficacy of UC-MSC treatment was monitored by pulmonary function.
Time Frame: 2 months
The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index).
2 months
The efficacy of UC-MSC treatment was measured by lab Indicators.
Time Frame: 2 months
The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein).
2 months

Collaborators and Investigators

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

Investigators

  • Study Director: Zewu Qiu, M.D., Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
  • Principal Investigator: 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

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)

May 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

April 1, 2015

More Information

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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