Thymus Transplantation With Immunosuppression (NCT00579709) | Clinical Trial Compass
CompletedPhase 1
Thymus Transplantation With Immunosuppression
United States15 participantsStarted 2002-07
Plain-language summary
The research purpose is to determine if thymus transplantation with immunosuppression is a safe and effective treatment for complete DiGeorge anomaly. The research includes studies to evaluate whether thymus transplantation results in complete DiGeorge anomaly subjects developing a normal immune system.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Transplant Inclusion
* No age limit
* Thyroid studies must be done and if abnormal, must be on therapy
DiGeorge diagnosis - must have 1 symptom from the following list:
* Heart defect
* Hypocalcemia requiring replacement
* 22q11 hemizygosity
* 10p13 hemizygosity
* CHARGE association
* Abnormal ears plus mother with diabetes (type I, type II, or gestational)
Atypical Diagnosis:
* Must have, or have had, a rash. If rash present, biopsy of rash must show T cells in skin. If rash \& adenopathy resolved, must still have oligoclonal T cells.
* Within 1 month of tx must have PHA response \>20 fold above background or \>5,000 cpm, whichever is higher, or response can be \< this.
* Circulating CD3+ T cells \>50/mm3 but CD45RA+CD62L+CD3+ T cells \<50/mm or \<5% of CD3 count, whichever is higher (must be done 2x)
* Immunoscope with \>40% oligoclonal TCRBV families. A 2nd test per sponsor discretion if T cell numbers increase or activation status changes.
* If TREC done pre-tx must have TRECs \<100 per 100,000 CD3+ cells.
Typical Diagnosis:
* Circulating CD3+ CD45RA+ CD62L+ T cells and \<50/mm3 or \<5% of total T cells
* PHA response \>20 fold above background or \>5,000 cpm, whichever is higher.
* 2 studies must show similar immunological findings qualify for this study.
* TRECs, if done, should be \<100/100,000 CD3 cells
Transplant Exclusion:
* Heart surgery \<4 weeks pre-tx date
* Heart surgery anticipated w/in 3 months of proposed tx
* Rejection by surgeon or anesthesiologis…
What they're measuring
1
Safety & tolerability of Thymoglobulin and cyclosporine followed by thymus transplantation: Survival at 1 year post-transplantation.