Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Belarusian State Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with allogenic parathyroid cells | Experimental | Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells |
|
| Control | Active Comparator | Patients with postoperative hypoparathyroidism receiving standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic parathyroid cells | Biological | Allogenic parathyroid cells |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrei Hancharou, Dr | Contact | +375296248972 | hancharou@ibp.org.by | |
| Tatyana Pozniak, Dr | Contact | +375173642358 | tatyana.pozniak@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrei Hancharou, Dr | the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Study Director |
| Stanislav Treatiak, Prof | Belarusian State Medical University | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard treatment according to the Clinical protocols | Other | Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols |
|
| Andrei Bolshov, Dr | Belarusian State Medical University | Principal Investigator |