NCT05186883

Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.

Detailed description

The cells will be isolated and cultured from the parathyroid gland of brain-dead organ donors. Cells will be tested for the immunophenotype, viability, sterility and the production of parathyroid hormone. Cells will be co-cultured with the patients T-cells and the expression of perforin and granzyme B proteins will be assayed as well as the apoptosis/viability of parathyroid cells. Prepared cells will be used to treat the patients with postoperative hypoparathyroidism. The safety, tolerability and clinical efficacy will be studied.

Conditions

• Postoperative Hypoparathyroidism

Interventions

Type	Name	Description
BIOLOGICAL	Allogenic parathyroid cells	Allogenic parathyroid cells
OTHER	Standard treatment according to the Clinical protocols	Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-01-11
• Last updated: 2022-01-13