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 transplantatio
- Conditions
- First line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
- Registration Number
- JPRN-UMIN000032819
- Lead Sponsor
- The Institute of Medical Science, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: 1) Incidence of Dose Limited Toxicity (DLI) and determination of optical dose for phase II studies. 2) Evaluation of adverse events such as the rate of events, until 11 weeks after the last administration of IMSUT-CORD. 3) Statistical evaluation of laboratory tests until 11 weeks after the last administration of IMSUT-CORD.
- Secondary Outcome Measures
Name Time Method Efficacy: 1) Overall response and change of stage/grading of organ damages by acute GVHD at 11 weeks after the last administration of IMSUT-CORD 2) Overall survival (OS)