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Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products

Who can join

All ages · All sexes

Inclusion Criteria:

1. Enrolled in an SCTx GTP clinical trial;
2. Received or planned to receive an SCTx GTP;
3. Subject and/or legally authorized representative have provided consent/assent for study participation.

About the study

Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.

What is being tested

• Long term follow up in all patients who received an SCTx gene therapy product (other)

Sponsor: Seattle Children's Hospital · Participants: 500 · Started: Jun 15, 2026

Contact the study team

• Adam Lamble · Phone: 206-987-2106

Official record on ClinicalTrials.gov — NCT07424157

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.