Treatment of Postoperative Hypoparathyroidism Using Cultured Allogenic Parathyroid Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 主要终点
- PTH in blood serum
研究概览
简要总结
The idea of the project is to develop a method of treatment of postoperative hypoparathyroidism using cultured allogenic parathyroid cells.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PTH in blood serum
时间窗: 1 year
The concentration of PTH in blood serum
Adverse effects associated with the therapy
时间窗: 1 year
Determination of adverse effects associated with the therapy
次要结局
未报告次要终点