Using your own fat-derived cells injected into the duodenum to help control type 2 diabetes
Official title: Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus
Run by Kaiser Clinic and Hospital · NCT07487467 · Data updated 2026-11-12
This study will try injecting a person's own fat-derived cell mix into the duodenal lining to see if it improves blood sugar control in adults with type 2 diabetes who are not using insulin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Kaiser Clinic and Hospital Academic / other |
| Locations | 1 site (São Jose Do Rio Preto, São Paulo) |
| Status | Recruiting |
| Started | January 20, 2025 |
| Main results expected | March 16, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07487467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with type 2 diabetes diagnosed less than 10 years ago, BMI ≥25 kg/m², HbA1c between 7.5% and 9.5%, C-peptide >1.0 nmol/L, and treated with metformin and/or pioglitazone (with or without sulfonylurea) are ideal candidates.
✕Probably not a fit
People with type 1 or autoimmune diabetes, positive anti-GAD antibodies, those on insulin or GLP-1/SGLT2/DPP-4 therapies, pregnant or breastfeeding individuals, or those with long-standing/advanced disease are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
About 40 mL of abdominal fat will be harvested using a 1210-nm diode laser One-STEP technique, and the stromal vascular fraction (SVF) will be isolated by double centrifugation without enzymatic digestion. The autologous SVF, which contains adipose-derived mesenchymal stem cells and supporting cells, will be injected into the duodenal submucosa during the same procedure. Five adults with type 2 diabetes meeting entry criteria will be followed for six months with metabolic testing, measures of pancreatic function (including C-peptide), and quality-of-life assessments. The trial is small and primarily designed to provide preliminary safety, feasibility, and early efficacy signals of this regenerative approach.
Why it matters
Potential benefit: If successful, the procedure could improve blood sugar control and possibly support pancreatic beta-cell function using the patient's own cells.
How similar studies have gone: Early preclinical work and small clinical reports of adipose-derived mesenchymal stem cells show some promising metabolic effects, but direct injection of SVF into the duodenal submucosa is novel and lacks larger confirmatory trials.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Kaiser Clinica
São Jose Do Rio Preto, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Luiz Gustavo' Quadros, PhD
- Email: gustavo_quadros@hotmail.com
- Phone: +55 17 98138-8737
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.