Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Postoperative Hypoparathyroidism

Treatments: Other: Standard treatment according to the Clinical protocols; Biological: Allogenic parathyroid cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05186883

IBCE_Parathyr

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment with allogenic parathyroid cells

Experimental group

Description:

Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells

Treatment:

Other: Standard treatment according to the Clinical protocols

Biological: Allogenic parathyroid cells

Control

Active Comparator group

Description:

Patients with postoperative hypoparathyroidism receiving standard treatment

Treatment:

Other: Standard treatment according to the Clinical protocols