Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury
NCT ID: NCT02444858
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous injection
UCMSC group
Human umbilical cord MSCs are transplanted by intravenous injection(5×10\^5/kg) ，once a day,a total of three times.
Control group(Normal saline)
Patients will receive normal saline at the same time points as that in experimental group.
Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.
Interventions
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UCMSC group
Human umbilical cord MSCs are transplanted by intravenous injection(5×10\^5/kg) ，once a day,a total of three times.
Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
15 Years
60 Years
ALL
No
Sponsors
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Ivy Institute of Stem Cells Co. Ltd
INDUSTRY
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Bing Liu, M.D.
Role: STUDY_CHAIR
307-IVY Translational Medicine Center
Zewu Qiu, M.D.
Role: STUDY_DIRECTOR
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Haochun Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Xiaobo Peng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Chunyan Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Locations
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Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307-IVY-SC-004
Identifier Type: -
Identifier Source: org_study_id
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