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Clinical Trial Report

Gene Therapy Trial Report

Summary

Autologous Hematopoietic Stem Cell Gene Therapy for Metachromatic Leukodystrophy and Adrenoleukodystrophy


NCTID NCT02559830 (View at clinicaltrials.gov)
Description
Indication Metachromatic Leukodystrophy, Adrenoleukodystrophy
Compound Name CD34+ hematopoietic stem cells transduced with ABCD1
Sponsor Shenzhen Second People's Hospital
Funder Type Other
Status
Recruiting
Enrollment Count 50

Therapy Information


Target Gene/Variant ABCD1
Therapy Type Gene transfer
Therapy Route Ex-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intravenous
Drug Product Type Autologous cells
Target Tissue/Cell CD34+ cells
Delivery System Viral transduction
Vector Type LV
Editor Type none
Dose 1 2E6 transduced CD34+ cells/kg (maximum 20E6)
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2015-08-12
Completion Date 2025-10
Last Update 2022-05-31

Participation Criteria


Eligible Age 1 Year - 16 Years
Standard Ages Child
Eligible Sex ALL

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND
Recent Updates

Resources/Links


Resources/Links

No External Links Available.