Parathyroid and Thymus Transplantation in DiGeorge #931

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

August 31, 2007

Study Completion Date

December 31, 2019

Conditions
DiGeorge SyndromeHypoparathyroidismComplete DiGeorge Syndrome
Interventions
BIOLOGICAL

Thymus/Parathyroid Transplantation

Thymus tissue, thymus donor, mother of thymus donor, \& parental parathyroid donor screened for transplant safety. Depending on T cell phenotype \& function, subjects were given 1 of 2 immunosuppression regimes. All received rabbit anti thymocyte globulin pretransplantation. Others also received cyclosporine pre \& post-transplantation. The thymus dose was over 0.2 grams/kg recipient weight. Thymus transplant occurred in operating room; thymic slices were placed in quadriceps. Parathyroid harvest was done under general anesthesia. One parathyroid gland was minced and placed in quadriceps muscle. There was no dose in mg. An open biopsy of thymus allograft was done 2-3 months post-transplant. Biopsy tissue was examined by immunohistochemistry to evaluate for thymopoiesis \& graft rejection.

Trial Locations (1)

27705

Duke University Medical Center, Durham

All Listed Sponsors
collaborator

Food and Drug Administration (FDA)

FED

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Sumitomo Pharma Switzerland GmbH

INDUSTRY

NCT00566488 - Parathyroid and Thymus Transplantation in DiGeorge #931 | Biotech Hunter | Biotech Hunter