Registry for patients with congenital athymia treated with RETHYMIC
Official title: Congenital Athymia Patient Registry of RETHYMIC
Run by Sumitomo Pharma Switzerland GmbH · NCT05329935 · Data updated 2026-11-12
This study is tracking kids with congenital athymia who have received a new treatment called RETHYMIC to see how well it helps their immune system and overall health over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 21 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Sumitomo Pharma Switzerland GmbH Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 25, 2022 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT05329935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients diagnosed with congenital athymia who are scheduled for or have recently undergone RETHYMIC treatment.
✕Probably not a fit
Patients who cannot provide informed consent or assent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry follows pediatric patients diagnosed with congenital athymia who have been treated with RETHYMIC, a cultured thymus tissue intervention. It employs a prospective cohort design to gather data on immune reconstitution, long-term survival, and adverse events following treatment. Patients are recruited within 60 days post-treatment or scheduled for treatment within 30 days. Clinical data and flow cytometry results will be collected at baseline and during follow-up at specified intervals.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term effects of RETHYMIC treatment on immune function and survival in patients with congenital athymia.
How similar studies have gone: While this registry approach is observational, previous studies with RETHYMIC have shown promising results in immune reconstitution, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Duke University School of Medicine
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: John Sleasman, M.D.
- Email: john.sleasman@duke.edu
- Phone: 919-684-9914
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating bone health in women with uterine fibroids or endometriosis using a medication
This study is testing if a new medication can help improve bone health in women with uterine fibroids or endometriosis who have heavy bleeding or pain.
-
Observational study on the safety of relugolix therapy in pregnant women
This study is trying to see if relugolix therapy is safe for pregnant women and their babies by looking at health outcomes during and after pregnancy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.