Acute GvHD. Graft-versus-host disease
Conditions
Interventions
Intervention 1: Intervention group: intravenous injection of a solution containing mesenchymal stem cells obtained from the human placenta is performed in 20 patients with acute graft-versus-host dise
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Barkhordar
Tehran University of Medical Sciences
Outcome results
None listed