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

Recruiting now · Not applicable

Conditions studied: Graft-Versus-Host Disease, Hematopoietic Stem Cell Transplantation, Child, Only, Haploidentical Hematopoietic Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT06423131

Run by

Sijia Gu

People needed

110

Starts

2024-05-26

Expected to finish

2028-03-31

Last updated by the study team

2024-05-29

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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