RecruitingNot Applicable

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

China3 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range7 Years – 10 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

chimeric status

Timeframe: 1 year after transplantation.

Trial details

NCT IDNCT06734520

SponsorGuangzhou Women and Children's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-01

Contact for this trial

Hua Jiang, Doctor

86-020-38076501 jiang_hua18@sina.cn

View on ClinicalTrials.gov More Thalassemia Majors (Beta-Thalassemia Major) trials