NCT07487467

Autologous SVF Therapy for Type 2 Diabetes

Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Kaiser Clinic and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Adipose-Derived Stromal Vascular Fraction (SVF)	Autologous adipose tissue will be harvested using a 1210-nm diode laser-assisted liposuction technique (One-STEP™). The lipoaspirate will undergo double centrifugation without collagenase digestion to isolate stromal vascular fraction enriched with mesenchymal stem cells. The isolated SVF will be immediately injected into the duodenal submucosa during the same operative session.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-03-16
• Completion: 2026-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Brazil