RecruitingNot ApplicableNCT06734520
Clinical Study of Super Transplantation in the Treatment of Severe β-thalassemia
Sponsor
Guangzhou Women and Children's Medical Center
Enrollment
3 participants
Start Date
Oct 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This is a single-arm, open label, phase 1 study in subjects with beta-thalassemia. This study will evaluate the safety and efficacy of preconditioning-free super-transplantation on beta-thalassemia pediatric patients.
Eligibility
Min Age: 7 YearsMax Age: 10 Years
Inclusion Criteria5
- Diagnosis of severe β -thalassemia
- Age between 7-10 years old, male and female; Weight \< 40kg
- The patient has or does not have an HLA-compatible or semi-compatible donor, but unconditional transplantation or refusal of blood stem cell transplantation; Patients with thalassemia gene therapy without conditions or refusal;
- There are fully compatible or incompatible HLA donors, and the physical examination meets the donor conditions;
- The patient and family members agree to receive hypertransplant therapy and sign a written informed consent prior to the transplant trial.
Exclusion Criteria4
- Mental patients;
- Participants in other drug clinical trials within the past 1 month;
- There are no suitable HLA-incompatible donors.
- Other researchers decide that it is not suitable to participate in this researcher.
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Interventions
DRUGsuper-transplantation in 3 severe β -thalassemia pediatric patients.
Haplo-identical donors are mobilized with G-CSF and PBMCs that contain CD34+ stem cells and CD3+ lymphocytes will be extracted by blood cell separators. Then the patients will be infused with the PBMC
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06734520