Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Phase 1

• Conditions: Postoperative Hypoparathyroidism
• Interventions: Biological: Allogenic parathyroid cells; Other: Standard treatment according to the Clinical protocols

• Registration Number: NCT05186883
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-23
• Status Verified: 2022-01
• Study First Posted: 2022-01-11
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13
• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinical diagnosis of postoperative hypoparathyroidism
• Decreased PTH concentrations in blood serum
• The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
• Written informed consent

Exclusion Criteria

• The presence of any malignant tumor within the last 5 years
• Acute or chronic diseases in the stage of decompensation
• Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
• Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
• Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
• Patients are unable or unwilling to give written informed consent and / or follow research procedures
• Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with allogenic parathyroid cells	Standard treatment according to the Clinical protocols	Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells
Control	Standard treatment according to the Clinical protocols	Patients with postoperative hypoparathyroidism receiving standard treatment
Treatment with allogenic parathyroid cells	Allogenic parathyroid cells	Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells

Primary Outcome Measures

Name	Time	Method
PTH in blood serum	1 year	The concentration of PTH in blood serum
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy