Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

January 12, 2022 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment with allogenic parathyroid cells
Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells
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
ACTIVE_COMPARATOR: Control
Patients with postoperative hypoparathyroidism receiving standard treatment
Other: Standard treatment according to the Clinical protocols
Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects associated with the therapy
Time Frame: 1 month
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Time Frame: 1 year
Determination of adverse effects associated with the therapy
1 year
PTH in blood serum
Time Frame: 3 month
The concentration of PTH in blood serum
3 month
PTH in blood serum
Time Frame: 6 month
The concentration of PTH in blood serum
6 month
PTH in blood serum
Time Frame: 1 year
The concentration of PTH in blood serum
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: Stanislav Treatiak, Prof, Belarusian State Medical University
  • Principal Investigator: Andrei Bolshov, Dr, Belarusian State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_Parathyr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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