Autologous SVF Therapy for Type 2 Diabetes

NCT07487467 | Recruiting

• 2 other identifiers: Stem Cells and DM2CAAE 69143523.9.0000.0281
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Adipose-Derived Stem Cells; Stromal Vascular Fraction; Mesenchymal Stem Cells; GLP-1; Regenerative Medicine

Outcome Measures

Primary Outcomes (1)

• Change in Fasting Plasma Glucose (mg/dL)

  The primary outcome is the change in fasting plasma glucose levels (mg/dL) from baseline to 6 months after autologous stromal vascular fraction (SVF) injection into the duodenal submucosa. Fasting plasma glucose will be measured after an overnight fast of at least 8 hours.

  Baseline and 6 months post-procedure

Study Arms (1)

Autologous SVF Duodenal Injection

EXPERIMENTAL

Participants with Type 2 Diabetes Mellitus will undergo abdominal adipose tissue harvesting using a 1210-nm diode laser-assisted selective photochemical stimulation technique (One-STEP™ method). The lipoaspirate will be processed by centrifugation without enzymatic digestion to isolate stromal vascular fraction (SVF) enriched with mesenchymal stem cells. The isolated SVF will be injected into the duodenal submucosa during the same surgical procedure. Participants will be followed for six months to assess metabolic outcomes and safety.

Biological: Autologous Adipose-Derived Stromal Vascular Fraction (SVF)

Interventions

Autologous Adipose-Derived Stromal Vascular Fraction (SVF) BIOLOGICAL

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.

Also known as: SVFD DM2

Autologous SVF Duodenal Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

Kaiser Clinica

São Jose Do Rio Preto, São Paulo, 15.015-110, Brazil

RECRUITING

Related Publications (5)

• Centurion P, Gamarra R, Caballero G, et al. Optimizing harvesting for facial lipografting with a new photochemical stimulation concept: One STEP technique™. Eur J Plast Surg. 2020;43(6):733-742.

  BACKGROUND

• Bhansali A, Asokumar P, Walia R, et al. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-1085.

  BACKGROUND

• Zang L, Li Y, Hao H, et al. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in adults with type 2 diabetes: randomized placebo-controlled phase II trial. Stem Cell Res Ther. 2022;13:180.

  BACKGROUND

• Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008;8(9):726-736.

  BACKGROUND

• Zuk PA, Zhu M, Mizuno H, et al. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001;7(2):211-228.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Luiz Gustavo' Quadros, PhD

CONTACT

+55 17 98138-8737; gustavo_quadros@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, open-label interventional feasibility study designed to evaluate the safety and preliminary efficacy of autologous adipose-derived stromal vascular fraction (SVF) enriched with mesenchymal stem cells in patients with Type 2 Diabetes Mellitus. All participants will undergo adipose tissue harvesting using a 1210-nm diode laser-assisted photochemical stimulation technique (One-STEP™ method), followed by same-procedure centrifugation and immediate endoluminal injection of SVF into the duodenal submucosa. Participants will be followed for six months to assess metabolic outcomes, pancreatic function, medication adjustment, and quality of life.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: January 20, 2025
• Primary Completion: March 16, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

BR (1)