Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

NCT ID: NCT05186883

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Hypoparathyroidism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with allogenic parathyroid cells

Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells

Group Type EXPERIMENTAL

Allogenic parathyroid cells

Intervention Type BIOLOGICAL

Allogenic parathyroid cells

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

Control

Patients with postoperative hypoparathyroidism receiving standard treatment

Group Type ACTIVE_COMPARATOR

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

Interventions

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Allogenic parathyroid cells

Allogenic parathyroid cells

Intervention Type BIOLOGICAL

Standard treatment according to the Clinical protocols

Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei Hancharou, Dr

Role: STUDY_DIRECTOR

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

Stanislav Treatiak, Prof

Role: STUDY_DIRECTOR

Belarusian State Medical University

Andrei Bolshov, Dr

Role: PRINCIPAL_INVESTIGATOR

Belarusian State Medical University

Central Contacts

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Andrei Hancharou, Dr

Role: CONTACT

+375296248972

Tatyana Pozniak, Dr

Role: CONTACT

+375173642358

Other Identifiers

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IBCE_Parathyr

Identifier Type: -

Identifier Source: org_study_id

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