MSC for Severe aGVHD
Phase 2
- Conditions
- Steroid-resistant Severe aGVHD
- Interventions
- Biological: MSCs
- Registration Number
- NCT03631589
- Lead Sponsor
- Fujian Medical University
- Brief Summary
Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Signed written informed consent
- Aged <65 years
- Patients with steroid-resistant severe aGVHD
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Exclusion Criteria
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of MSCs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MSCs treated MSCs -
- Primary Outcome Measures
Name Time Method complete and partial response rate 1 year
- Secondary Outcome Measures
Name Time Method Adverse events that are related to treatment 1 year
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China