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Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

Primary Purpose

Postoperative Hypoparathyroidism

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Allogenic parathyroid cells
Standard treatment according to the Clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Hypoparathyroidism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment with allogenic parathyroid cells

    Control

    Arm Description

    Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells

    Patients with postoperative hypoparathyroidism receiving standard treatment

    Outcomes

    Primary Outcome Measures

    PTH in blood serum
    The concentration of PTH in blood serum
    PTH in blood serum
    The concentration of PTH in blood serum
    PTH in blood serum
    The concentration of PTH in blood serum
    Adverse effects associated with the therapy
    Determination of adverse effects associated with the therapy
    Adverse effects associated with the therapy
    Determination of adverse effects associated with the therapy

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2021
    Last Updated
    January 12, 2022
    Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05186883
    Brief Title
    Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
    Official Title
    Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Hypoparathyroidism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment with allogenic parathyroid cells
    Arm Type
    Experimental
    Arm Description
    Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients with postoperative hypoparathyroidism receiving standard treatment
    Intervention Type
    Biological
    Intervention Name(s)
    Allogenic parathyroid cells
    Intervention Description
    Allogenic parathyroid cells
    Intervention Type
    Other
    Intervention Name(s)
    Standard treatment according to the Clinical protocols
    Intervention Description
    Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols
    Primary Outcome Measure Information:
    Title
    PTH in blood serum
    Description
    The concentration of PTH in blood serum
    Time Frame
    3 month
    Title
    PTH in blood serum
    Description
    The concentration of PTH in blood serum
    Time Frame
    6 month
    Title
    PTH in blood serum
    Description
    The concentration of PTH in blood serum
    Time Frame
    1 year
    Title
    Adverse effects associated with the therapy
    Description
    Determination of adverse effects associated with the therapy
    Time Frame
    1 month
    Title
    Adverse effects associated with the therapy
    Description
    Determination of adverse effects associated with the therapy
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrei Hancharou, Dr
    Phone
    +375296248972
    Email
    hancharou@ibp.org.by
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tatyana Pozniak, Dr
    Phone
    +375173642358
    Email
    tatyana.pozniak@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrei Hancharou, Dr
    Organizational Affiliation
    the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Stanislav Treatiak, Prof
    Organizational Affiliation
    Belarusian State Medical University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Andrei Bolshov, Dr
    Organizational Affiliation
    Belarusian State Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells

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