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 type | Interventional |
|---|---|
| Ages | 8 Weeks to 18 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | May 26, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | May 29, 2024 |
| Trial ID | NCT06423131 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
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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.
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Using Ruxolitinib to prevent complications after haploidentical stem cell transplants
This study is testing if the drug Ruxolitinib can help prevent complications like graft-versus-host disease in patients receiving stem cell transplants from partially matched donors.
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Population PK-guided ATG Dosing in Haploidentical Stem Cell Transplant
This trial tests a population PK-guided ATG dosing strategy in people undergoing haploidentical hematopoietic stem cell transplantation to see if it improves outcomes.
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Population PK-guided ATG Dosing in Haplo-HSCT
This study tests a population PK-guided dosing strategy for anti-thymocyte globulin (ATG) in adults and adolescents undergoing haploidentical stem cell transplantation to see if it can reduce GVHD while keeping relapse risk acceptable.
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Two Different Therapeutic Distractions Used During Blood Draw for Children Aged 5–7
This study tests whether two distraction methods during blood sampling can reduce pain, fear, and anxiety in 5–7 year-olds compared with routine care.
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Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children
This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.
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Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant
This study tests whether an anti-CD25 antibody can better prevent acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation compared with the usual methotrexate-based approach.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.