Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Fasting Plasma Glucose (mg/dL)
研究概览
简要总结
This prospective clinical study aims to evaluate the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF), enriched with mesenchymal stem cells (ADSCs), for the treatment of Type 2 Diabetes Mellitus (T2DM).
Adipose tissue will be harvested using a 1210-nm diode laser-assisted selective photochemical stimulation technique (One-STEP™ method), followed by centrifugation without enzymatic digestion. The isolated SVF will be injected endoluminally into the duodenal submucosa during the same surgical procedure.
Five adult patients with T2DM will be followed for six months to assess metabolic control, pancreatic function, and quality of life outcomes.
详细描述
Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder characterized by insulin resistance and beta-cell dysfunction. Current therapeutic approaches primarily aim to improve insulin sensitivity and glycemic control but do not restore pancreatic beta-cell function or incretin signaling.
The duodenum plays a central role in metabolic signaling and insulin sensitivity regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may improve glycemic control.
Adipose-derived mesenchymal stem cells (ADSCs), obtained from stromal vascular fraction (SVF), have demonstrated immunomodulatory and regenerative properties. The One-STEP™ selective tissue engineering photostimulation technique (1210-nm diode laser) enables preservation of adipocytes and ADSCs without enzymatic digestion, maintaining high cell viability and surface marker expression.
In this study, 40 mL of abdominal subcutaneous adipose tissue will be harvested using laser-assisted photochemical stimulation (Medilaser S 1210 nm). The lipoaspirate will undergo double centrifugation (800g and 700g) to isolate SVF without collagenase. The resulting pellet will be injected into the duodenal submucosa during the same procedure.
Participants will be monitored for six months with metabolic and quality of life assessments.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Both sexes
- •Diagnosis of Type 2 Diabetes Mellitus for less than 10 years
- •BMI ≥ 25 kg/m²
- •HbA1c between 7.5% and 9.5%
- •C-peptide > 1.0 nmol/L
- •Use of metformin and/or pioglitazone, with or without sulfonylurea
排除标准
- •Type 1 Diabetes Mellitus or autoimmune diabetes
- •Positive anti-GAD antibodies
- •Pregnancy or breastfeeding
- •Use of insulin therapy
- •Use of SGLT2 inhibitors
- •Use of DPP-4 inhibitors
- •Use of GLP-1 receptor agonists
- •Unknown duration of diabetes
结局指标
主要结局
Change in Fasting Plasma Glucose (mg/dL)
时间窗: Baseline and 6 months post-procedure
The primary outcome is the change in fasting plasma glucose levels (mg/dL) from baseline to 6 months after autologous stromal vascular fraction (SVF) injection into the duodenal submucosa. Fasting plasma glucose will be measured after an overnight fast of at least 8 hours.
次要结局
未报告次要终点