Congenital Athymia Patient Registry

NCT05329935 · tracked via the Priya Life Science USA tracker

Sponsor

Sumitomo Pharma Switzerland GmbH

Phase

Observational

Started

2022-05-25

Last updated

2025-08-19

Condition(s) studied

Complete DiGeorge AnomalyComplete DiGeorge SyndromeCongenital Athymia

Investigational drug(s) / intervention(s)

Cultured Thymus Tissue

Cultured Thymus Tissue: Product will be surgically administered into the quadriceps

Study summary

This Congenital Athymia Patient Registry is an observational exposure-based registry study. It uses a prospective cohort design to follow patients who have been treated with RETHYMIC.

Clinical studies conducted with investigational RETHYMIC showed that treatment can result in immune reconstitution and prolong life. This treatment-based registry is being conducted to learn more about the reconstitution process following treatment and the impact of treatment on longer-term survival and the occurrence of adverse events of special interest (AESI).

Eligibility

Sex

ALL

Min age

0 Years

Max age

21 Years

Healthy volunteers

Inclusion Criteria: * Pediatric patients diagnosed with Congenital Athymia: * Who are scheduled for implantation with RETHYMIC within the next 30 days, or who were treated with RETHYMIC within the previous 60 days. * Who have provided written informed consent directly, or written informed consent has been provided by the patient, the parent, or legal guardian. Exclusion Criteria: * Written informed consent cannot be obtained.

Primary outcome measure(s)

Vital Status — 12 months post treatment with RETHYMIC.
Flow cytometry including total and naïve CD3, CD4, and CD8 counts — Immediately after the intervention/procedure/surgery

Trial sites (1)

Facility	City	Region	Status
Duke University School of Medicine	Durham	North Carolina	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05329935 on ClinicalTrials.gov ↗ ← All trials in the USA