Co-transplantation of MSC in the Setting of Allo-HSCT
Phase 2
Recruiting
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Interventions
- Biological: Cotransplant with MSCs
- Registration Number
- NCT04247945
- Lead Sponsor
- Fujian Medical University
- Brief Summary
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Signed written informed consent
- Aged <65 years
- Willing to transplant
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description MSC+HSC Cotransplant with MSCs -
- Primary Outcome Measures
Name Time Method Survival Rate up to 2 years after HSCT
- Secondary Outcome Measures
Name Time Method Incidence of Systemic Infections up to 2 years after HSCT Rates of Relapse up to 2 years after HSCT Mean Time to Engraftment Baseline to engraftment, assessed minimally 28 days post transplant Transplant-Related Mortality up to 1 months after HSCT Cumulative Incidence of Graft-versus Host Disease up to 2 years after HSCT
Trial Locations
- Locations (1)
Union Hospital,Fujian Medical University
🇨🇳Fuzhou, Fujian, China