NCT01068951已完成不适用
Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells
研究概览
简要总结
The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent
- •Mentally stable and able to comply with the procedures of the study protocol
- •Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide >0.1 nmol/l
排除标准
- •Patients with BMI>30
- •Patients with unstable cardiovascular status
- •Patients with active infections, unless treatment is not judged necessary by the investigators
- •Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.
- •Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.
- •Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.
研究组 & 干预措施
Mesenchymal stem cells
Active Comparator
Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus.
干预措施: Mesenchymal stem cells (Biological)
结局指标
主要结局
The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells
时间窗: 1 year after intervention
次要结局
未报告次要终点
研究者
Per-Ola Carlsson
Professor
Uppsala University Hospital
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes PatientsDiabetes Mellitus, Insulin-DependentDiabetes MellitusDiabetes Mellitus, Type 1NCT04078308Royan Institute20
已完成
4 期
Protection Against Pneumococcal Infection in Children With T1DMType 1 Diabetes MellitusNCT01939522University of Oxford50
已完成
不适用
The Impact of a Diabetes Risk Prediction Model in Primary Care.Primary PreventionType 2 Diabetes MellitusNCT03234322German Diabetes Center315
已完成
不适用
Pilot Study of Auto-immune Abnormalities Associated With Down SyndromeDown Syndrome With and Without Auto Immune AbnormalitiesNCT01041469Institut Jerome Lejeune72
已完成
不适用
Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal IrradiationChildhood Cancer Survivors Treated With Abdominal RadiationNCT02248779Memorial Sloan Kettering Cancer Center42