Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

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

Detailed Description
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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.

Official Title
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Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Conditions
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Postoperative Hypoparathyroidism

Intervention / Treatment
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* Biological: Allogenic parathyroid cells
* Other: Standard treatment according to the Clinical protocols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with allogenic parathyroid cells<br>Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells | Biological: Allogenic parathyroid cells<br>* Allogenic parathyroid cells<br>Other: Standard treatment according to the Clinical protocols<br>* Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols<br>|
| Active Comparator: Control<br>Patients with postoperative hypoparathyroidism receiving standard treatment | Other: Standard treatment according to the Clinical protocols<br>* Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH in blood serum | The concentration of PTH in blood serum | 3 month | 
| PTH in blood serum | The concentration of PTH in blood serum | 6 month | 
| PTH in blood serum | The concentration of PTH in blood serum | 1 year | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month | 
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year |