Overview
This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.
Description
1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion.
Eligibility
Inclusion Criteria:
- Age 8 weeks to 18 years
- Children who meet the indicators haploidentical hematopoietic cell transplantation
- No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness
- Informed consent must be signed (by the patient or legal representative)
Exclusion Criteria:
- Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
- Chronic active viral hepatitis
- Ejection fraction <50%
- Respiratory failure necessitating supplemental oxygen
- Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study
- Patients unwilling or unable to comply with the protocol or unable to give informed consent
- Concurrent severe or uncontrolled infection