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A Phase I/II, Open Labeled, Monocentric Study of Direct Intracranial Administration of a Replication Deficient Adeno-associated Virus Gene Transfer Vector Serotype Rh.10 Expressing the Human ARSA CDNA to Children with Metachromatic Leukodystrophy.

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Trial Profile

A Phase I/II, Open Labeled, Monocentric Study of Direct Intracranial Administration of a Replication Deficient Adeno-associated Virus Gene Transfer Vector Serotype Rh.10 Expressing the Human ARSA CDNA to Children with Metachromatic Leukodystrophy.

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs Arylsulfatase A gene therapy (Primary)
  • Indications Metachromatic leukodystrophy
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms TG-MLD

Most Recent Events

  • 04 Feb 2025 Status changed from active, no longer recruiting to completed.
  • 10 Jan 2022 Planned End Date changed from 1 Apr 2019 to 1 May 2029.
  • 20 Jul 2017 Planned End Date changed from 1 Apr 2018 to 1 Apr 2019.

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