Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients
Recruiting
Early Phase 1
Interventional Study
β-thalassemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 8 – 16
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Shenzhen Hemogen · Industry
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About This Trial
This is an open label study to evaluate the safety and efficacy of β-globin Restored Autologous Hematopoietic Stem Cells in ß-Thalassemia Major Patients
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 8-16 years old. Subject and/or subject's legal guardian fully understand and voluntarily sign informed consent;
* Clinically diagnosed as transfusion-dependent β-thalassemia major;
* With sufficient RBC infusion, subjects must maintain hemoglobin ≥9g/dL, serum ferritin thresho…
Contacts