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

Lung Injury Clinical Trial

— UCMSC-PQLI  

Official title:

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444858
• Other study ID #: 307-IVY-SC-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 12, 2015
• Last updated: May 12, 2015
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Zewu Qiu, M.D.
• Phone: +86-010-66947376
• Email: qiuzw828[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Injury
• Paraquat Poisoning
• Poisoning

Intervention

Biological:
• UCMSC group
Human umbilical cord MSCs are transplanted by intravenous injection(5×10^5/kg) ,once a day,a total of three times.

Other:
• Control group(Normal saline)
Normal saline in same volume as MSCs are transplanted to patients.

Locations

Country	Name	City	State
China	Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	Ivy Institute of Stem Cells Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months	Yes
Secondary	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.	2 months	No
Secondary	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).	2 months	No
Secondary	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).	2 months	No
Secondary	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).	2 months	No