Phase I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation - Phase 1 trial with IMSUT-CORD for treatment-resistant severe acute GVHD

Tojo Arinobu0 个研究点目标入组 6 人开始时间: 2019年1月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Patients with grade II to IV acute GVHD. Pathological diagnosis is required, if possible.
•2. Patients resistant to standard therapy with glucocorticoid.
•3. Patients who can give their consent by the written form.

•1. Patients NOT treated with standard first-line treatment with glucocorticoid for acute GVHD (except for prevention therapy for acute GVHD).
•2. Patients treated with hematopoietic stem cell transplantation for hematopoietic malignancies under no remission, except for myelodysplastic syndrome with or without leukemic transition and myeloproliferative diseases.
•3. Patients with following severe complications within 14 days before registration.
•a) Cardiac function: Ejection fraction <40%
•b) Pulmonary function: SpO2 < 90% or SpO2 < 95% under oxygen inhalation.
•c) Renal function: serum creatinine -> 2 times of upper limit of institutional normal range (ULN).
•d) Liver function: serum total bilirubin ->3 times of ULN, AST/ALT -> 5 times of ULN.
•4. Pregnant/possible pregnant and nursing woman. Patients refuse to contraception.
•5. Patients positive for HIV antibodies, HTLV-I antibodies, HBs antigen, and HCV antibodies.
•6. Therapy resistant hypertension
•7. Patient who have allergy against reagents used for processing, such as amphotericin B, gentamicin. Patients treated as emergency for adverse reaction of DMSO.
•8. Investigators decision as not eligible.

发起方

Tojo Arinobu