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Clinical Study of Super Transplantation in the Treatment of Severe ฮฒ-thalassemia

RecruitingNAAges 7 Years - 10 YearsAllGuangzhou Women and Children's Medical Center
NCT06734520 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of severe ฮฒ -thalassemia 2. Age between 7-10 years old, male and female; Weight \< 40kg 3. 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; 4. There are fully compatible or incompatible HLA donors, and the physical examination meets the donor conditions; 5. The patient and family members agree to receive hypertransplant therapy and sign a written informed consent prior to the transplant trial. Exclusion Criteria: 1. Mental patients; 2. Participants in other drug clinical trials within the past 1 month; 3. There are no suitable HLA-incompatible donors. 4. Other researchers decide that it is not suitable to participate in this researcher.
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What it tests

  • super-transplantation in 3 severe ฮฒ -thalassemia pediatric patients.
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Where

2 sites
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, China
Guangzhou Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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