Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells (NCT05186883) | Clinical Trial Compass
UnknownPhase 1/2
Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
20 participantsStarted 2022-03-01
Plain-language summary
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
PTH in blood serum
Timeframe: 3 month
2
PTH in blood serum
Timeframe: 6 month
3
PTH in blood serum
Timeframe: 1 year
4
Adverse effects associated with the therapy
Timeframe: 1 month
5
Adverse effects associated with the therapy
Timeframe: 1 year
Trial details
NCT IDNCT05186883
SponsorInstitute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus