Postoperative HypoparathyroidismPhase 1/2NCT05186883
Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
A Phase 1/2 study testing Allogenic parathyroid cells and Standard treatment according to the Clinical protocols in people with Postoperative Hypoparathyroidism, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.
Trial summary
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Hypoparathyroidism
- What is being tested?
- Allogenic parathyroid cells and Standard treatment according to the Clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.
Read the 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.
- Conditions
- Postoperative Hypoparathyroidism
- Being tested
- Allogenic parathyroid cells, Standard treatment according to the Clinical protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic parathyroid cellsBiological
Allogenic parathyroid cells
Standard treatment according to the Clinical protocolsOther
Standard treatment of postoperative hypoparathyroidism according to the Clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| Treatment with allogenic parathyroid cells | Experimental | Patients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells Receives: Biological: Allogenic parathyroid cells; Other: Standard treatment according to the Clinical protocols |
| Control | Active comparator | Patients with postoperative hypoparathyroidism receiving standard treatment Receives: Other: Standard treatment according to the Clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTH in blood serum
The concentration of PTH in blood serum
Measured: 3 month
PTH in blood serum
The concentration of PTH in blood serum
Measured: 6 month
PTH in blood serum
The concentration of PTH in blood serum
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Dr, Study director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusStanislav Treatiak, Prof, Study director, Belarusian State Medical UniversityAndrei Bolshov, Dr, Principal investigator, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186883
- Sponsor's protocol ID
- IBCE_Parathyr
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
- ClinicalTrials.gov ID
- NCT05186883
- Acronym / sponsor ID
- IBCE_Parathyr
- Conditions
- Postoperative Hypoparathyroidism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with allogenic parathyroid cells | Experimental | Biological: Allogenic parathyroid cells, Other: Standard treatment according to the Clinical protocolsPatients with postoperative hypoparathyroidism receiving standard treatment and allogenic parathyroid cells |
| Control | Active comparator | Other: Standard treatment according to the Clinical protocolsPatients with postoperative hypoparathyroidism receiving standard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogenic parathyroid cellsAllogenic parathyroid cells | Biological | Treatment with allogenic parathyroid cells |
| Standard treatment according to the Clinical protocolsStandard treatment of postoperative hypoparathyroidism according to the Clinical protocols | Other | Control, Treatment with allogenic parathyroid cells |
Primary outcome
PTH in blood serum
Time frame: 3 month
The concentration of PTH in blood serum
PTH in blood serum
Time frame: 6 month
The concentration of PTH in blood serum
PTH in blood serum
Time frame: 1 year
The concentration of PTH in blood serum
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Postoperative Hypocalcemia After Thyroidectomy
Thyroid Nodule, Thyroid Dysfunction
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Risk Factors for Hypoparathyroidism Following Thyroidectomy
Post-Surgical Hypoparathyroidism
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Calcium Replacement Therapy in Postoperative Hypoparathyroidism
Post-Thyroidectomy Hypoparathyroidism Treatment
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PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"
Postoperative Hypoparathyroidism, Postsurgical Hypoparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Hancharou, Dr study director
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Stanislav Treatiak, Prof study director
Belarusian State Medical University
Andrei Bolshov, Dr principal investigator
Belarusian State Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogenic parathyroid cells and Standard treatment according to the Clinical protocols in people with Postoperative Hypoparathyroidism, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrei Hancharou, Dr (+375296248972, hancharou@ibp.org.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTH in blood serum (time frame: 3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.