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• W1974846837 abstract "O203 Aims: Due to the various metabolic functions of parathyroid hormone (PTH) satisfactory treatment of permanent hypoparathyroidism after thyroid and parathyroid surgery remains difficult. Previous trials with allotransplantation of human parathyroid tissue failed because of rejection. Encapsulation of tissue and cells with alginates or alternative substances is a promising approach for biological drug delivery. Besides their immunoisolation abilities semi-permeable membranes of capsules ensure acess to nutrients or oxygen and transfer of peptide hormones. Methods: in vitro studies: An established human parathyroid cell culture model was used to examine 30 cryopreserved specimens from patients with secondary hyperparathyroidism. We analyzed PTH secretion and function before and after microencapsulation of cell cultures with sodium cellulose sulphate (NaCS) and Poly-DADMAC (poly(diallyldimethylammoniumchloride)). Clinical phase II studies: After successful in vivo testing of a highly purified alginate in a rat model with excellent graft function and calcium homeostasis beyond 32 weeks we designed a clinical phase II trial including 10 patients with permanent hypoparathyroidism. Until now two patients received 20 capsules (diameter approx. 2 mm) with tissue from donors operated because of secondary hyperparathyroidism. Transplant recipients were analyzed for PTH course, immunological status, need for medication and quality of life. Results: in vitro studies: Cell viability of cryopreserved tissue in culture increased from 72% (±11,7) to 97% (±4,3) after two days. Physiological responsiveness to calcium suppression was still intact and comparable to the encapsulated group. Mean capsule diameter was 0,39 mm (±0,09), while pore size was 1,39 nm (1,27 – 1,47) on average. PTH secretion of encapsulated cells in cell culture medium increased increased from 2157 pg/ml (±295) 3 days after encapsulation to 5193 pg/ml (±835) at day 9. Long term studies show a further linear increase up to 80 days after encapsulation. Clinical phase II studies: So far three patients have been transplanted. The first patient (male, 30 years) had a history of severe hypoparathyroidism after surgery for Graves’ disease. PTH was below detection limit, even with high doses of substitution therapy symptoms were persistent. After transplantation PTH values increased up to a subnormal range, whereas calcium levels and clinical pathology increased significantly with half of the initial substitution doses. Symptoms of incompatibility were not visible, the immune status showed a slight and temporarily activation. Contrary to our expectations transplantation in the second patient (female, 55 years) had no effect. PTH and calcium levels as well as quality of life did not increase. There was no immune activation, adverse effects were not detectable. A third patient (female, 44 years) was transplanted 2 weeks ago. The postoperative course was without pathological findings, evaluation of graft function will be possible in a few weeks. Conclusions: Encapsulation of monolayer parathyroid cultures with NaCS and Poly-DADMAC in vitro generated promising results, immunoisolation abilities have to be verified in further allotransplantation studies. Clinical phase II studies with a highly purified and biomedical suitable alginate showed ambiguous therapeutical effects, adverse effects or symptoms of incompatibility were not detectable. However results are preliminary." @default.
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• W1974846837 date "2004-07-01" @default.
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• W1974846837 title "ALLOTRANSPLANTATION OF ENCAPSULATED HUMAN PARATHYROID TISSUE IN PATIENTS WITH PERMANENT HYPOPARATHYROIDISM" @default.
• W1974846837 doi "https://doi.org/10.1097/00007890-200407271-00216" @default.
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