A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients

Description

The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase (AADC) deficiency.

Conditions

AADC Deficiency

Study Overview

Study Details

Study overview

The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase (AADC) deficiency.

SIngle-Stage, Open-Label, Safety and Efficacy Study of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase by Magnetic Resonance MR-guided Infusion Into Midbrain in Pediatric Patients With AADC Deficiency

A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients

Condition
AADC Deficiency
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, Benioff Children's Hospital, San Francisco, California, United States, 94143

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Columbus

The Ohio State University Medical Center, Columbus, Ohio, United States, 43221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    24 Months to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Krzysztof Bankiewicz,

    Krystof Bankiewicz, MD, PhD, STUDY_DIRECTOR, OSU Professor of Neurological Surgery

    Study Record Dates

    2031-07