ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02444858
Recruitment Status : Unknown
Verified April 2015 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Collaborator:
Ivy Institute of Stem Cells Co. Ltd
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Paraquat Poisoning Lung Injury Biological: UCMSC group Other: Control group(Normal saline) Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

Arm Intervention/treatment
Experimental: UCMSC group
Human umbilical cord MSCs are administrated to patients by intravenous injection
Biological: 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.
Other: Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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).

  3. 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).

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444858


Contacts
Contact: Zewu Qiu, M.D. +86-010-66947376 qiuzw828@163.com

Locations
China
Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences Recruiting
Beijing, China, 100071
Contact: Zewu Qiu, M.D.    +86-010-66947376    qiuzw828@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Ivy Institute of Stem Cells Co. Ltd
Investigators
Study Chair: Bing Liu, M.D. 307-IVY Translational Medicine Center
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

Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02444858     History of Changes
Other Study ID Numbers: 307-IVY-SC-004
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: April 2015

Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences:
paraquat poisoning
lung injury
stem cell therapy
human umbilical cord mesenchymal stem cell
phase 1/2 clinical study
allogeneic stem cell transplantation

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Poisoning
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Chemically-Induced Disorders