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Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product | Clinical Trials | Clareo Health

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Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

NCT02698579•Genetix Biotherapeutics Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study (Study ALD-102 or Study ALD-104). After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.

Eligibility

Age

0 - 19 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Provision of written informed consent for this study by the participant or participant's parent(s)/ legal guardian(s) and written informed assent by participant, if applicable
•Have received eli-cel in a parent clinical study

Locations (13)

Mattel Children's Hospital-UCLA

Los Angeles, California, United States

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, United States

Boston Children's Hospital/Massachusetts General Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Instituto Neurogenia

Caba, Argentina

Women's and Children's Hospital

North Adelaide, Australia

Hospital das Clínicas da Universidade de São Paulo

São Paulo, Brazil

Hôpital Bicêtre

Le Kremlin-Bicêtre, Cedex, France

Universitätsklinikum Leipzig AöR

Leipzig, Germany

Ospedale Pediatrico Bambino Gesù

Rome, Italy

Key Dates

Start Date

January 22, 2016

Primary Completion Date

August 1, 2038

Completion Date

August 1, 2038

Last Updated

February 20, 2025

Enrollment

ACTUAL participants

Conditions

Cerebral Adrenoleukodystrophy (CALD)Adrenoleukodystrophy (ALD)X-Linked Adrenoleukodystrophy (X-ALD)

Interventions

No interventional drug product utilized in this follow-up study

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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