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NCT07487467Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
17 Mar 2026
Start date
20 Jan 2025
Primary completion date
16 Mar 2026
Lead sponsor
Kaiser Clinic and Hospital
NCT number
NCT07487467

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 20 Jan 2025 to the primary completion date, 16 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Positive anti-GAD antibodies
  • Use of insulin therapy
  • Use of SGLT2 inhibitors
  • Use of DPP-4 inhibitors

Other illness

  • Type 1 Diabetes Mellitus or autoimmune diabetes
  • Unknown duration of diabetes

Other

  • Pregnancy or breastfeeding
  • Use of GLP-1 receptor agonists

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kaiser Clinica
Coordinator of this site? Confirm its status
São Jose Do Rio PretoBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.