Clinical trial Recruiting at 1 site Interventional Ages 8 Weeks to 18

Comparing two types of stem cell transplants for children

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

Run by Shanghai Jiao Tong University School of Medicine · NCT06423131 · Data updated 2026-11-12

This study is testing whether a new type of stem cell transplant can reduce complications and improve life for children who need this treatment.

Quick facts

Study typeInterventional
Ages8 Weeks to 18 Years
SexAll
Enrollment110 (estimated)
SponsorShanghai Jiao Tong University School of Medicine
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedMay 26, 2024
Main results expectedMarch 31, 2027
Study endsMarch 31, 2028
Registry record updatedMay 29, 2024
Trial IDNCT06423131 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 8 weeks to 18 years who require haploidentical hematopoietic cell transplantation and do not have suitable HLA matched donors.

Probably not a fit

Patients with severe liver function abnormalities, chronic active viral hepatitis, or other significant health issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of TCRαβ depleted haploidentical stem cell transplantation compared to the traditional Beijing protocol in children requiring hematopoietic stem cell transplantation. It is a single-center, prospective, non-randomized controlled study conducted in China. The goal is to achieve a 30% reduction in the incidence of grade II-IV acute graft-versus-host disease (aGVHD) and to improve the quality of life for patients receiving the TCRαβ depleted cells.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of aGVHD and enhance the quality of life for pediatric patients undergoing stem cell transplantation.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in reducing aGVHD in other transplant settings, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

  • Principal investigator: Jing Chen, PhD — Shanghai Children's Medical Center
  • Study coordinator: Jing Chen, PhD
  • Email: chenjing@scmc.com.cn
  • Phone: 38626161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.