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Clinical Trials/IRCT20140818018842N40
IRCT20140818018842N40
Recruiting
Phase 1

Evaluaing the safety and effectiveness of intravenous infusion of placenta-derived mesenchymal stem cells and placenta-derived mesenchymal stem cell exosomes in steroid-resistant acute GvHD patients; Phase I and II clinical trial

Tehran University of Medical Sciences0 sites60 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acute GvHD.
Sponsor
Tehran University of Medical Sciences
Enrollment
60
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Acute aGvHD grade II\-IV according to MAGIC criteria and steroid resistant according to EBMT\-NIH\-CIBMTR
  • A patient who underwent allogeneic HSCT with the following conditions: HLA\-matched donor (MRD), HLA\-mismatched donor (MUD), unrelated cord blood (UCB), haploidal donor

Exclusion Criteria

  • Positive serology for hepatitis B, hepatitis C and AIDS virus or fungal infection
  • Patients with penicillin and/or gentamicin allergy or known allergy to cow or pork products
  • Participants with uncontrolled diseases including persistent or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or specific social situations that limit compliance with study requirements
  • Any condition that, in the investigator's judgment, interferes with full participation in the study, including the administration of study medication or participation in required study visits, or poses a significant risk to the participant, or interferes with the interpretation of study data
  • Transplant recipient for solid tumor
  • Diagnosis of Sinus Obstructive Syndrome (SOS) or Venous Obstructive Disease, at any time of study with appropriate tests
  • Pregnancy and breastfeeding

Outcomes

Primary Outcomes

Not specified

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