None listed
Conditions
Brief summary
Background: Severe graft-versus-host disease (GVHD) and graft rejection are still major complications of haploidentical stem cell transplantation, especially for haploidentical nonmyeloablative transplantation (Haploidentical-NST). Many data have shown that bone marrow–derived mesenchymal stem cells (MSCs) have some immunosuppressive capability and enhancing hematopoietic engraftment. Based on our previous researches on the phase I clinical trial of MSCs in humans and experiment of monkeys rhesus model, we designed a new strategy that included cotransplantation of MSCs with Haploidentical-NST, in order to improve the effectiveness of haploidentical transplantation in high-risk acute leukemia patients.
Interventions
It consisted of fludarabine 30mg/m2/day (days –6 to -2), total body irradiation (60Co) 2Gy(day -1), cyclophosphamide (CTX) 40 mg/kg/day (days -4, -2), Ara-C (cytarabine) 1.5~2.0 g/m2 (days -6 to -3), and rabbit anti-human thymocyte globulin (ATG, France) 1.5~2.0 mg/kg/d (days -4 to -1). mesenchymal stem cells administrated by Intra-bone Marrow injection into iliac bones 30 min before hematopoietic stem cells infusion at day 0.
Sponsors
Huisheng Ai
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
9 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
High risk leukemia patients
Exclusion criteria
The patients with blast cells is over 50% in bone marrow after chemotherapy
Outcome results
None listed