UnknownNot Applicable

Patients Treated for SCID (1968-Present)

United States1,007 participantsStarted 2011-05-15

Plain-language summary

Individuals with a past diagnosis of severe combined immune deficiency (including many cases of "leaky SCID", Omenn syndrome, and reticular dysgenesis) who have undergone blood and marrow transplant, gene therapy, or enzyme replacement in the past may be eligible for this study. The purpose of study is to look backwards at what has already been done in the. Over 800 patients with SCID are expected to be enrolled, making this one of the largest studies ever to describe outcomes for patients with SCID treated at many different hospitals around North America.

Who can participate

SexALL

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Inclusion criteria

✓-were treated at a location participating in this consortium from 1968 until present, and
✓-are not enrolled in RDCRN PIDTC-6901 (ClinicalTrials.gov ID: NCT01186913).
✓. Reduced number of CD3 T cells,
✓. \> 80% of CD3+ or CD4 T cells are CD45RO+,
✓Individuals who meet the following criteria and were treated with PEG-ADA or gene therapy with autologous modified cells are eligible for enrollment into Stratum C (SCID with non-HCT treatments) of the study-

What they're measuring

Retrospective Study - Part 1

Timeframe: 1, 5, 10, 20, >20 years

Cross-Sectional Study - Part 2

Timeframe: 2 to > 20 years

Trial details

NCT IDNCT01346150

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2023-08

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