---
title: Congenital Athymia Patient Registry
nct_id: NCT05329935
overall_status: RECRUITING
sponsor: Sumitomo Pharma Switzerland GmbH
study_type: OBSERVATIONAL
primary_condition: Complete DiGeorge Anomaly
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05329935.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05329935"
ct_last_update_post_date: 2025-08-19
last_seen_at: "2026-05-12T06:47:39.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Congenital Athymia Patient Registry

**Official Title:** Congenital Athymia Patient Registry of RETHYMIC

**NCT ID:** [NCT05329935](https://clinicaltrials.gov/study/NCT05329935)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** Sumitomo Pharma Switzerland GmbH
- **Conditions:** Complete DiGeorge Anomaly, Complete DiGeorge Syndrome, Congenital Athymia
- **Start Date:** 2022-05-25
- **Completion Date:** 2026-04
- **CT.gov Last Update:** 2025-08-19

## Brief 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).

## Detailed Description

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).

Currently, there is a single site where patients are being treated with RETHYMIC. The Investigator will be responsible for recruiting patients who have recently had (i.e., within the past 60 days) or are scheduled to have this treatment within 30 days and obtaining signed informed consent (and assent as applicable). The Investigator will collect baseline medical history and clinical data information for each enrolled subject. The start of follow-up (day 1) begins on the day following treatment surgery. Clinical data and flow cytometry test results (when conducted) will be abstracted from the medical records by Clinical Staff at baseline and during follow-up at predefined intervals.

## Eligibility

- **Minimum age:** 0 Years
- **Maximum age:** 21 Years
- **Sex:** ALL

```
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.
```

## Arms

- **Main cohort** — All eligible patients
- **Secondary cohort** — All eligible patients who survived 1 year post treatment

## Interventions

- **Cultured Thymus Tissue** (BIOLOGICAL) — Product will be surgically administered into the quadriceps

## Primary Outcomes

- **Vital Status** _(time frame: 12 months post treatment with RETHYMIC.)_
- **Flow cytometry including total and naïve CD3, CD4, and CD8 counts** _(time frame: Immediately after the intervention/procedure/surgery)_

## Secondary Outcomes

- **AESI classified by MedDRA coding, severity and grade** _(time frame: Immediately after the intervention/procedure/surgery)_

## Locations (1)

- Duke University School of Medicine, Durham, North Carolina, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.duke university school of medicine|durham|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05329935.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05329935*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*