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Safety and Efficacy Evaluation of β-globin Restored Autologous Hematopoietic Stem Cells in β-thalassemia Major Patients

NCT05745532 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-29

No results posted yet for this study

Summary

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

Conditions

  • β-thalassemia

Interventions

BIOLOGICAL

β-globin restored autologous hematopoietic stem cells

β-globin-restored autologous hematopoietic stem cells modified with LentiHBBT87Q

Sponsors & Collaborators

  • Shenzhen Hemogen

    lead INDUSTRY

Principal Investigators

  • Chao Liu, PHD · Shenzhen Hemogen

  • Sixi Liu, Professor · Shenzhen Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-05-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05745532 on ClinicalTrials.gov