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

Launched by AFFILIATED HOSPITAL TO ACADEMY OF MILITARY MEDICAL SCIENCES · May 12, 2015

Keywords

ClinConnect 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.

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 z...

Gender

ALL

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)