RecruitingNCT05329935

Congenital Athymia Patient Registry

Congenital Athymia Patient Registry of RETHYMIC


Sponsor

Sumitomo Pharma Switzerland GmbH

Enrollment

75 participants

Start Date

May 25, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 0 YearsMax Age: 21 Years

Inclusion Criteria3

  • 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 Criteria1

  • Written informed consent cannot be obtained.

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Interventions

BIOLOGICALCultured Thymus Tissue

Product will be surgically administered into the quadriceps


Locations(1)

Duke University School of Medicine

Durham, North Carolina, United States

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NCT05329935