Comparing two types of stem cell transplants for children
TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 8 Weeks to 18 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06423131 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe liver function abnormalities, chronic active viral hepatitis, or other significant health issues may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in reducing aGVHD in other transplant settings, indicating potential for success.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.