Autologous SVF Therapy for Type 2 Diabetes

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT07487467

Run by

Kaiser Clinic and Hospital

People needed

10

Starts

2025-01-20

Expected to finish

2026-12-31

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Clinica — São Jose Do Rio Preto, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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