the Safety and Efficacy Evaluation of HGI-002 Injection in Patients With Transfusion-Dependent α-Thalassemia
NCT05851105 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2024-11-29
Summary
This is an open label study to evaluate the safety and efficacy of α-globin Restored Autologous Hematopoietic Stem Cells in α-Thalassemia Major Patients
Conditions
- α-thalassemia
Interventions
- BIOLOGICAL
-
α-globin restored autologous hematopoietic stem cells
α-globin restored autologous hematopoietic stem cells modified with LentiHBA T\>C
Sponsors & Collaborators
-
Shenzhen Hemogen
lead INDUSTRY
Principal Investigators
-
Chao Liu, PHD · Shenzhen Hemogen
-
Xinhua Zhang · PLA Joint Logistic Support Force No. 923 Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-08
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
Countries
- China
Study Locations
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