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

Primary Purpose

Paraquat Poisoning, Lung Injury

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCMSC group
Control group(Normal saline)
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paraquat Poisoning focused on measuring paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

UCMSC group

Control group(Normal saline)

Arm Description

Human umbilical cord MSCs are administrated to patients by intravenous injection

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The efficacy of UC-MSC treatment was measured clinical evaluation.
The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before.
The efficacy of UC-MSC treatment was measured by chest computerized tomography.
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).
The efficacy of UC-MSC treatment was monitored by pulmonary function.
The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index).
The efficacy of UC-MSC treatment was measured by lab Indicators.
The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein).

Full Information

First Posted
May 12, 2015
Last Updated
May 12, 2015
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02444858
Brief Title
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury
Acronym
UCMSC-PQLI
Official Title
Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Ivy Institute of Stem Cells Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraquat Poisoning, Lung Injury
Keywords
paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCMSC group
Arm Type
Experimental
Arm Description
Human umbilical cord MSCs are administrated to patients by intravenous injection
Arm Title
Control group(Normal saline)
Arm Type
Other
Arm Description
Patients will receive normal saline at the same time points as that in experimental group.
Intervention Type
Biological
Intervention Name(s)
UCMSC group
Intervention Description
Human umbilical cord MSCs are transplanted by intravenous injection(5×10^5/kg) ，once a day,a total of three times.
Intervention Type
Other
Intervention Name(s)
Control group(Normal saline)
Intervention Description
Normal saline in same volume as MSCs are transplanted to patients.
Primary Outcome Measure Information:
Title
Safety will be determined by the assessment of major adverse events.
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The efficacy of UC-MSC treatment was measured clinical evaluation.
Description
The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before.
Time Frame
2 months
Title
The efficacy of UC-MSC treatment was measured by chest computerized tomography.
Description
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).
Time Frame
2 months
Title
The efficacy of UC-MSC treatment was monitored by pulmonary function.
Description
The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index).
Time Frame
2 months
Title
The efficacy of UC-MSC treatment was measured by lab Indicators.
Description
The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zewu Qiu, M.D.
Phone
+86-010-66947376
Email
qiuzw828@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Liu, M.D.
Organizational Affiliation
307-IVY Translational Medicine Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zewu Qiu, M.D.
Organizational Affiliation
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haochun Wang, M.D.
Organizational Affiliation
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaobo Peng, M.D.
Organizational Affiliation
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunyan Wang, M.D.
Organizational Affiliation
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zewu Qiu, M.D.
Phone
+86-010-66947376
Email
qiuzw828@163.com

12. IPD Sharing Statement

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Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury

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