Investigator initiated trial to evaluate the safety and efficacy of umbilical cord blood-derived mesenchymal stem cells for treatment of pediatric patients with steroid-refractory acute or chronic graft versus host disease.
Not Applicable
Recruiting
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000389
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. Steroid-refractory acute or chronic graft-versus-host-disease
2. Acquisition of consent form
3. 0-30 years of age
Exclusion Criteria
1. Withdrawal from the study
2. Progression of underlying hematologic diseases
3. Severe adverse effects related to the investigational drug
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety(Vital sign, Physical examination, ECOG performance status/Adverse effects related to infusion);Treatment response of GVHD
- Secondary Outcome Measures
Name Time Method Pediatric Quality of Life inventory