The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety of using allogenic ASC assessed by any adverse events
研究概览
简要总结
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
详细描述
Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.
Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.
The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.
These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients with Type 1 Diabetes Mellitus.
- •Age from 18 years to 35 years either gender.
- •Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
- •C-Peptide at inclusion base line should not be less than 0.5 ng/ml
- •No clinical evidence of renal, retinal, vascular or skin complications
- •Body Mass Index not exceeding 30
- •At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
- •Informed Consent by patient
排除标准
- •Age less than 18 years and more than 35 years
- •Married women or women expected to be married within the study period
- •History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
- •Diabetic coma or pre-coma current or recent within the last 2 months
- •C-Peptide less than 0.5 ng/ml
- •Disease duration more than 3 yrs.
- •Complication mentioned in 5 above in inclusion
- •Non-consenting patient or withdrawal of consent.
- •Bleeding disorders
研究组 & 干预措施
Dose 1 mil/kg
Adipose mesenchymal cells with bone marrow mononuclear cells.
Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +1 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.
干预措施: Adipose mesenchymal cells with bone marrow mononuclear cells (Biological)
Dose 10 mil/kg
Adipose mesenchymal cells with bone marrow mononuclear cells.
Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +10 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.
干预措施: Adipose mesenchymal cells with bone marrow mononuclear cells (Biological)
结局指标
主要结局
Safety of using allogenic ASC assessed by any adverse events
时间窗: 6 months
Patients will be assessed for any adverse events as a result of the injection.
次要结局
未报告次要终点
研究者
Sophia Al-Adwan
Biologist, PhD
University of Jordan