Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
