Clinical trial NCT02444858: Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ivy Institute of Stem Cells Co. Ltd
First posted: 2015-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Safety will be determined by the assessment of major adverse events.
timeFrame: 2 months
Secondary outcomes:
measure: The efficacy of UC-MSC treatment was measured clinical evaluation.
timeFrame: 2 months
measure: The efficacy of UC-MSC treatment was measured by chest computerized tomography.
timeFrame: 2 months
measure: The efficacy of UC-MSC treatment was monitored by pulmonary function.
timeFrame: 2 months
measure: The efficacy of UC-MSC treatment was measured by lab Indicators.
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: 307-IVY Translational Medicine Center
name: Bing Liu, M.D.
role: STUDY_CHAIR
affiliation: Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
name: Zewu Qiu, M.D.
role: STUDY_DIRECTOR
affiliation: Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
name: Haochun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
name: Xiaobo Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
name: Chunyan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: