NCT07487467 Autologous SVF Therapy for Type 2 Diabetes
| NCT ID | NCT07487467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaiser Clinic and Hospital |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2026-03-16 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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
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