Postoperative Hypoparathyroidism
Conditions
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.
Interventions
BIOLOGICALAllogenic parathyroid cells
Allogenic parathyroid cells
Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTH in blood serum | 3 month | The concentration of PTH in blood serum |
| Adverse effects associated with the therapy | 1 month | Determination of adverse effects associated with the therapy |
Contacts
Primary ContactAndrei Hancharou, Dr
Backup ContactTatyana Pozniak, Dr
Outcome results
None listed