RecruitingPhase 2ACTRN12608000129381

Cotransplantation of mesenchymal stem cells with nonmyeloablative haploidentical peripheral blood stem cells without T cells deleted for high-risk acute leukemia: to reduce the severity of graft versus host disease and relapse


Sponsor

Huisheng Ai

Enrollment

40 participants

Start Date

Mar 8, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 9 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new strategy for people with high-risk acute leukaemia (blood cancer) who need a stem cell transplant from a partially matched family member (haploidentical transplant). This type of transplant can be complicated by the donor immune cells attacking the patient's body (graft-versus-host disease) or the body rejecting the new stem cells. Researchers are testing whether adding special cells called mesenchymal stem cells (MSCs) to the transplant can make it safer and more effective by supporting engraftment and reducing complications. You may be eligible if: - You have been diagnosed with high-risk acute leukaemia - You are between 9 and 60 years of age You may NOT be eligible if: - After chemotherapy, more than 50% of your bone marrow cells are still blast cells (immature cancer cells) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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),

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.


Locations(1)

Beijing, China

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ACTRN12608000129381