Placenta-derived mesenchymal stem cells and placenta-derived mesenchymal stem cells exosomes in the treatment of acute GvHD

Phase 1

Recruiting

Conditions: Acute GvHD.
Graft-versus-host disease
D89.81

Registration Number: IRCT20140818018842N40

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events. Timepoint: day of injection, 1 and 2 weeks, 1, 3 and 6 months after the first injection. Method of measurement: History and clinical examination based on common terminological criteria for adverse events.

Secondary Outcome Measures

Name	Time	Method
Complete response rate. Timepoint: Day of injection, 1 and 2 weeks, 1, 3 and 6 months after the first injection. Method of measurement: Clinical examination.;Total survival rate. Timepoint: 0 to 6 months. Method of measurement: Clinical evaluation.