Actively Recruiting
Congenital Athymia Patient Registry of RETHYMIC
Led by Sumitomo Pharma Switzerland GmbH · Updated on 2025-08-19
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with Congenital Athymia who have been treated with RETHYMIC in this registry study. The goal is to understand the immune recovery process following treatment, the long-term survival of patients, and any special adverse events that may occur. RETHYMIC has shown potential to help rebuild the immune system and extend life in previous clinical studies. Patients receive an investigational treatment called Cultured Thymus Tissue, which is surgically implanted into the quadriceps muscle. The study follows patients prospectively, including those recently treated or scheduled to receive treatment within specific time frames. The registry collects medical history and clinical data from patient records at baseline and during follow-up visits. Participants are monitored starting the day after their treatment surgery. Researchers review clinical data and flow cytometry tests that measure immune cell counts. The main outcomes include vital status 12 months after treatment and detailed immune cell measurements right after surgery. The study also tracks any adverse events classified by severity. Follow-up and data collection continue to better understand treatment impact over time.
CONDITIONS
Brief Title
Congenital Athymia Patient Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients diagnosed with Congenital Athymia
- Scheduled for RETHYMIC implantation within the next 30 days or treated with RETHYMIC within the previous 60 days
- Written informed consent provided by the patient, parent, or legal guardian
You will not qualify if you...
- Written informed consent cannot be obtained
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day 1 (the day of surgery)
Participants undergo surgery to receive cultured thymus tissue implanted into the quadriceps as treatment.
1 surgery visit (in-person)
Duration - Up to 12 months post treatment
Participants are followed over time to monitor immune reconstitution, survival, and adverse events after treatment with RETHYMIC. Clinical data and test results are collected from medical records at predefined intervals.
Visits scheduled according to routine care and study assessments; frequency varies
Trial Site Locations
Total: 1 location
1
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
J
John Sleasman, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here