RecruitingNot ApplicableNCT05773729

Safety and Efficacy of Gene Modified Autologous Hematopoietic Stem Cells to Treat Transfusion-dependent Beta-thalassemia

Safety and Efficacy of Lentiviral Vector Transduction of β-globin Genetically Modified Autologous CD34+ Hematopoietic Stem Cells in Patients With Transfusion-dependent β-thalassemia


Sponsor

Shanghai BDgene Co., Ltd.

Enrollment

10 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will be intented to evaluate the safety, tolerability, and engraftment efficacy after myeloablative preconditioning and transplantation of autologous CD34+ hematopoietic stem cells transduced with a lentiviral vector encoding the human βA-T87Q-globin gene in patients with transfusion-dependent (TDT) β-thalassemia.


Eligibility

Min Age: 3 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BD211 for people with thalassemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICBD211

Genetically modified CD34+ autologous stem cells were transfused intravenously with single dosing.


Locations(1)

Shanghai Children's Medical Centre

Shanghai, China

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NCT05773729


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