- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444858
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
Study Overview
Status
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 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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Zewu Qiu, M.D.
- Phone Number: +86-010-66947376
- Email: qiuzw828@163.com
Study Locations
-
-
-
Beijing, China, 100071
- Recruiting
- Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
-
Contact:
- Zewu Qiu, M.D.
- Phone Number: +86-010-66947376
- Email: qiuzw828@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous injection
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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
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307-IVY-SC-004
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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