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

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lung Injury; Paraquat Poisoning

Treatments: Biological: UCMSC group; Other: Control group(Normal saline)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02444858

307-IVY-SC-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

UCMSC group

Experimental group

Description:

Human umbilical cord MSCs are administrated to patients by intravenous injection

Treatment:

Biological: UCMSC group

Control group(Normal saline)

Other group

Description:

Patients will receive normal saline at the same time points as that in experimental group.

Treatment:

Other: Control group(Normal saline)