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 I clinical trial with umbilical cord-derived mesenchymal stromal cells (IMSUT-CORD) for treatment-resistant severe acute graft-versus-host disease (GVHD)

The Institute of Medical Science, The University of Tokyo0 sites6 target enrollmentJune 1, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: First line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Sponsor: The Institute of Medical Science, The University of Tokyo
Enrollment: 6
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

June 1, 2018

End Date

June 29, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

The Institute of Medical Science, The University of Tokyo

•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.