Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorSijia Gu

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TCRαβ Depleted haploidentical HCT

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sijia Gu

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Sponsor institution