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Clinical trial

Congenital Athymia Patient Registry of RETHYMIC

ID
Name
RVT-802-4001
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).
Trial arms
Trial start
2022-05-25
Estimated PCD
2026-04-01
Trial end
2026-04-01
Status
Recruiting
Treatment
Cultured Thymus Tissue
Product will be surgically administered into the quadriceps
Arms:
Main cohort, Secondary cohort
Other names:
RETHYMIC, allogeneic cultured thymus tissue-agdc
Size
75
Primary endpoint
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
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

1 product

2 indications

Organization
Sumitomo Pharma Switzerland
Product
Cultured Thymus Tissue
Indication
DiGeorge Syndrome
Indication
Congenital Athymia