Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total daily insulin dose
研究概览
简要总结
To evaluate the safety and efficacy of Stem cells from human exfoliated teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
详细描述
Basic treatment:
The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).
Stem cell therapy:
Dosage: Stem cells from human exfoliated teeth were calculated at 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the purpose of clinical trials, willing to participate and sign informed consent;
- •Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic criteria and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year;
- •Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
- •Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months.
- •Age 25-70 years old, gender not limited;
- •Body mass index (BMI) : between 19 and 28kg/m2;
- •from the date of screening to the end of follow-up, male or female subjects of childbearing age will voluntarily take precautions Pregnancy; Urine pregnancy test was negative when screening women of childbearing age, and serum pregnancy test was performed when necessary to clearly exclude pregnancy.-
排除标准
- •Patients with gestational diabetes or other special types of diabetes;
- •Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
- •Patients who have received other stem cell therapy before screening;
- •Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
- •Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
- •Patients who have used insulin for less than 1 year before screening and only injected insulin subcutaneously once a day within the past 3 months;
- •Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
- •Patients with other malignant tumors or suspected tumor tendency;Or in the active phase of various infections (including active stage of HBV or HCV infection);Immunodeficiency virus (HIV) positive patients;
- •Patients with other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, immune system and blood system);
- •For patients with liver and kidney dysfunction, for example, serum bilirubin TBIL exceeds 1.5 times of the normal upper limit, AST and ALT exceed 2.5 times of the normal upper limit, and serum creatinine Cr exceeds 1.2 times of the normal upper limit;
- •Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
- •Disabled patients (blind, deaf, dumb, mentally retarded, physically disabled) as stipulated by law, pregnant women and lactating women;People suffering from mental illness;Patients who take drugs or have a history of adverse drug abuse and alcohol dependence within 5 years;
- •Patients with contraindications or allergies treated in this study;
- •Subjects who have participated in other clinical studies in the past 3 months.
研究组 & 干预措施
Stem cells from human exfoliated teeth
Basic treatment:
The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).
Stem cell therapy:
Dosage: Stem cells from human exfoliated teeth were calculated at 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.
干预措施: Stem cells from human exfoliated teeth (Biological)
结局指标
主要结局
Total daily insulin dose
时间窗: baseline and 1,2,6 week and 2,3,6,9,12 month
change from baseline during treatment
glucose-c peptide release test
时间窗: baseline and 1,2,6 week and 2,3,6,9,12 month
relative baseline change during treatment
次要结局
- Islet function(1 year)
- Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia(1 year)
- Continuous dynamic blood glucose(1 year)