One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome. Another purpose of this study is to determine whether parental parathyroid transplantation (in addition to cultured thymus tissue implantation (CTTI) can help both the immune and the calcium problems in DiGeorge infants with hypocalcemia. \[Funding Source - FDA Office of Orphan Products Development (OOPD)\]
Who can participate
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Thymus Transplant Inclusion Criteria:
* A parent or guardian of the DGS subject signed the consent form.
* Medical screening was completed.
* For a diagnosis of DGS, the subject had to have one of the following:
* Congenital heart disease;
* Hypocalcemia requiring replacement;
* 22q11.2 hemizygosity or 10p13 hemizygosity;
* CHARGE association or CHD7 mutation;
* A subject with abnormal ears whose mother had diabetes (type I, type II, or gestational).
* To meet the criteria of typical complete DiGeorge Anomaly (cDGA), the subject had to have either:
* Circulating CD3+ T cell count by flow cytometry \< 50/mm3 OR
* Circulating CD3+ T cells that were also positive for Cluster of Differentiation 45RA (CD45RA)+ CD62L+ and were \< 50/mm3 or less than 5% of total T cells.
Thymus Transplant Exclusion Criteria:
* Had heart surgery less than 4 weeks prior to projected implant date;
* Heart surgery anticipated within 3 months after the proposed time of implantation;
* Present or past lymphadenopathy;
* Rash associated with T cell infiltration of the dermis and epidermis;
* Rejection by the surgeon or anesthesiologist as surgical candidate;
* Lack of sufficient muscle tissue to accept a transplant of 4 g/m2 body surface area (BSA) or 0.2 g/kg subject bodyweight;
* Had human immunodeficiency virus (HIV) infection;
* Had prior attempts at immune reconstitution, such as bone marrow transplant or previous thymus transplantation;
* Ventilator support or positive pressure sup…