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Clinical Trials/JPRN-jRCT2033180077
JPRN-jRCT2033180077
Completed
Phase 1

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 sites6 target enrollmentJanuary 11, 2019
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ConditionsFirst line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD)Acute graft-versus-host disease (GVHD)D006086, D000208

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
First line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD)
Sponsor
Tojo Arinobu
Enrollment
6
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Tojo Arinobu

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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