Long-Term Follow-Up of Gene Therapy Patients Treated at Seattle Children's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational long-term follow-up study to monitor safety after exposure to SCTx gene therapy products. No new treatment is given; participants undergo scheduled safety assessments and lab tests related to their prior SCTx GTP infusions. The study follows individuals for up to 15 years from their most recent SCTx infusion, aligning with FDA guidance for extended safety monitoring. Eligibility requires prior or planned SCTx GTP treatment and informed consent. Conducted at Seattle Children's Hospital with Seattle Children's Hospital as the lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Adam Lamble
• Email: CBDCIntake@seattlechildrens.org
• Phone: 206-987-2106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.