Condition 1: hematopoietic stem cell transplantation. Condition 2: Graft Versus Host Disease. Condition 3: Graft Versus Host Disease. Stem cells transplant status Acute graft-versus-host disease Chronic graft-versus-host disease
Conditions
Interventions
Intervention 1: Intervention group: TGlobulin 25 (manufactured by Kawsar Biotech Company) with standard doses: haploidentical stem cell transplant, primary immunodeficiency patients: 2.5 mg/kg from da
Sponsors
Kowsar Biotechnology company
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1 to 18 year-old hematopoietic stem cell transplant recipients with anti-thymocyte globulin in their conditioning regimen parents or legally acceptable representatives must have provided a written informed consent Lansky score above 70% Absence of severe active infection use of bone marrow or G-CSF-stimulated peripheral blood stem cells
Exclusion criteria
Exclusion criteria: History of previous stem cell transplantation (re-transplantation) use of umbilical cord blood stem cells history of previous treatment with anti-thymocyte globulin in the last three months Known allergic reaction to rabbit proteins abnormal liver function (total bilirubin greater than three times the upper limit of normal (ULN), conjugated bilirubin> 2 mg/dl, transaminases greater than three times the ULN) abnormal renal function adjusted for the patient's age abnormal heart function (left ventricular ejection fraction < 50% after ECHO, congestive heart failure, arrhythmia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of acute GVHD. Timepoint: First 100 days after transplantation. Method of measurement: Physical examination and laboratory findings.;Overall survival. Timepoint: until 1 year after transplantation. Method of measurement: Mortality assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of chronic GVHD. Timepoint: From 100 days until 1 year after transplantation. Method of measurement: Physical examination and laboratory findings.;Rate of bacterial infections. Timepoint: until 1 year after transplantation. Method of measurement: Blood culture.;Rate of fungal infections. Timepoint: until 1 year after transplantation. Method of measurement: Laboratory test (Aspergillus galactomannan antigen in blood by ELISA).;Rate of viral infections. Timepoint: until 1 year after transplantation. Method of measurement: Laboratory test (RT-PCR for CMV infection).;Rejection. Timepoint: Until 1 month after transplantation. Method of measurement: evaluation of chimerism by Short tandem repeat or FISH. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Behfar
Tehran University of Medical Sciences
Outcome results
None listed