Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Postoperative Hypoparathyroidism Clinical Trial

Official title:

Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05186883
• Other study ID #: IBCE_Parathyr
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: Andrei Hancharou, Dr
• Phone: +375296248972
• Email: hancharou[@]ibp.org.by
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism
• Postoperative Hypoparathyroidism

Intervention

Biological:
• Allogenic parathyroid cells
Allogenic parathyroid cells

Other:
• Standard treatment according to the Clinical protocols
Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian State Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTH in blood serum	The concentration of PTH in blood serum	3 month
Primary	PTH in blood serum	The concentration of PTH in blood serum	6 month
Primary	PTH in blood serum	The concentration of PTH in blood serum	1 year
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year