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Diabetes Mellitus, Type 2LASER-DM2 TriaNCT07487467

Autologous SVF Therapy for Type 2 Diabetes

A study testing Autologous Adipose-Derived Stromal Vascular Fraction (SVF) in people with Diabetes Mellitus, Type 2, run by Kaiser Clinic and Hospital at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Autologous Adipose-Derived Stromal Vascular Fraction (SVF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBrazil
Study dates
20 Jan 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luiz Gustavo' Quadros, PhD contact

+55 17 98138-8737

gustavo_quadros@hotmail.com

Brazil1 site, 1 recruiting

  • Kaiser Clinica

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

    Recruiting

Other trials in Brazil

About this study

Official title: Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus

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.

Read the detailed description

Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder characterized by insulin resistance and beta-cell dysfunction. Current therapeutic approaches primarily aim to improve insulin sensitivity and glycemic control but do not restore pancreatic beta-cell function or incretin signaling.

The duodenum plays a central role in metabolic signaling and insulin sensitivity regulation. Emerging evidence suggests that gastrointestinal mucosal modulation may improve glycemic control.

Adipose-derived mesenchymal stem cells (ADSCs), obtained from stromal vascular fraction (SVF), have demonstrated immunomodulatory and regenerative properties. The One-STEP™ selective tissue engineering photostimulation technique (1210-nm diode laser) enables preservation of adipocytes and ADSCs without enzymatic digestion, maintaining high cell viability and surface marker expression.

In this study, 40 mL of abdominal subcutaneous adipose tissue will be harvested using laser-assisted photochemical stimulation (Medilaser S 1210 nm). The lipoaspirate will undergo double centrifugation (800g and 700g) to isolate SVF without collagenase. The resulting pellet will be injected into the duodenal submucosa during the same procedure.

Participants will be monitored for six months with metabolic and quality of life assessments.

Being tested
Autologous Adipose-Derived Stromal Vascular Fraction (SVF)
Keywords
Adipose-Derived Stem Cells, Stromal Vascular Fraction, Mesenchymal Stem Cells, GLP-1, Regenerative Medicine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called SVFD DM2

    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.

Study groups in NCT07487467
Study groupRoleWhat they receive
Autologous SVF Duodenal InjectionExperimentalParticipants 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.
Receives: Biological: Autologous Adipose-Derived Stromal Vascular Fraction (SVF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2026
  2. Study start20 Jan 2025
  3. Primary completion16 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07487467
Sponsor's protocol ID
Stem Cells and DM2
Other IDs
CAAE 69143523.9.0000.0281
Acronym
LASER-DM2 Tria
Status last verified
Mar 2026
First submitted
17 Mar 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision regarding individual participant data (IPD) sharing has not yet been finalized. Given the small sample size and the need to ensure participant confidentiality, data sharing policies will be defined after study completion in accordance with institutional regulations and applicable data protection laws.

Publications

  • 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.

  • Bhansali A, Asokumar P, Walia R, Bhansali S, Gupta V, Jain A, Sachdeva N, Sharma RR, Marwaha N, Khandelwal N. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus: a randomized placebo-controlled study. Cell Transplant. 2014;23(9):1075-85. doi: 10.3727/096368913X665576.

    PubMed 23561959

  • Zang L, Li Y, Hao H, Liu J, Cheng Y, Li B, Yin Y, Zhang Q, Gao F, Wang H, Gu S, Li J, Lin F, Zhu Y, Tian G, Chen Y, Gu W, Du J, Chen K, Guo Q, Yang G, Pei Y, Yan W, Wang X, Meng J, Zhang S, Ba J, Lyu Z, Dou J, Han W, Mu Y. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial. Stem Cell Res Ther. 2022 May 3;13(1):180. doi: 10.1186/s13287-022-02848-6.

    PubMed 35505375

  • Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008 Sep;8(9):726-36. doi: 10.1038/nri2395.

    PubMed 19172693

  • Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

    PubMed 11304456

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Adipose-Derived Stromal Vascular Fraction (SVF) in people with Diabetes Mellitus, Type 2, run by Kaiser Clinic and Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luiz Gustavo' Quadros, PhD (+55 17 98138-8737, gustavo_quadros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fasting Plasma Glucose (mg/dL) (time frame: Baseline and 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07487467, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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