CTRI/2017/12/010878Other2 期
A Prospective, Randomized, Multi-Centric, Comparative, Open Label, Double arm Controlled Clinical Study to Evaluate the Safety of UCMSCs in subjects with recently diagnosed Type 1 diabetes
Reliance Life Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male/female patients with age 12 to 35 years (both inclusive)
- •2.Subject must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria
- •3.Subject must be screened between 2 to 36 weeks (approximately 9 months) from initial T1DM diagnosis
- •4.Patients with basal C-peptide <= 0.1 ng/ml
- •5.Patients or legally acceptable representative (LAR) able to understand the study procedures, the risks involved, willing to provide written informed consent and able to adhere to study schedules and requirements
排除标准
- •1.Patients with history of diabetic ketoacidosis
- •2.Patients with evidence of retinopathy at baseline
- •3.Patients with unstable cardiovascular status
- •4.Patients with C-reactive protein (hs-CRP) >3.00 ng/ml
- •5.Patients with baseline hemoglobin below the lower limits of normal
研究者
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