Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 13, 2022
January 1, 2022
1.8 years
December 1, 2021
January 12, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
PTH in blood serum
The concentration of PTH in blood serum
3 month
PTH in blood serum
The concentration of PTH in blood serum
6 month
PTH in blood serum
The concentration of PTH in blood serum
1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
1 year
Study Arms (2)
Treatment with allogenic parathyroid cells
EXPERIMENTALPatients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells
Control
ACTIVE COMPARATORPatients with postoperative hypoparathyroidism receiving standard treatment
Interventions
Allogenic parathyroid cells
Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Andrei Hancharou, Dr
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- STUDY DIRECTOR
Stanislav Treatiak, Prof
Belarusian State Medical University
- PRINCIPAL INVESTIGATOR
Andrei Bolshov, Dr
Belarusian State Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
January 11, 2022
Study Start
March 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 13, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share