Status:

UNKNOWN

Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Lead Sponsor:

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

Collaborating Sponsors:

Belarusian State Medical University

Conditions:

Postoperative Hypoparathyroidism

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

PHASE2

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 horm...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05186883

Start Date

March 1 2022

End Date

December 31 2023

Last Update

January 13 2022

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