NCT02444858

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paraquat Poisoning
• Lung Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2015-05-15
• Last updated: 2015-05-15

Locations

1 site across 1 country: China