RecruitingNot ApplicableNCT06423131

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

TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation :A Single-center, Prospective, Non-randomized Controlled Clinical Study


Sponsor

Sijia Gu

Enrollment

110 participants

Start Date

May 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 8 WeeksMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

PROCEDURETCRαβ Depleted haploidentical HCT

Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children


Locations(1)

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT06423131


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