Clinical trial NCT05186883: Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
Official title: Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Hypoparathyroidism
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTH in blood serum
timeFrame: 3 month
measure: PTH in blood serum
timeFrame: 6 month
measure: PTH in blood serum
timeFrame: 1 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Adverse effects associated with the therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: Belarusian State Medical University
name: Stanislav Treatiak, Prof
role: STUDY_DIRECTOR
affiliation: Belarusian State Medical University
name: Andrei Bolshov, Dr
role: PRINCIPAL_INVESTIGATOR
References: