Clinical Study of Super Transplantation in the Treatment of Severe β-thalassemia
NCT06734520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2024-12-16
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.
Conditions
- Thalassemia Majors (Beta-Thalassemia Major)
- Haplo-identical Donors
Interventions
- DRUG
-
super-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
Sponsors & Collaborators
-
Guangzhou Women and Children's Medical Center
lead OTHER
Principal Investigators
-
Hua Jiang, PHD · Guangzhou Medical University Affiliated Women's and Children's Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2029-07-01
- Completion
- 2029-07-01
Countries
- China
Study Locations
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