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
About this trial
This is an interventional treatment trial for Postoperative Hypoparathyroidism
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
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
NCT ID
NCT05186883
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
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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