Evaluation of Autologous Adipose-Derived Stromal Vascular Fraction Obtained by 1210-nm Laser Photostimulation for the Treatment of Type 2 Diabetes Mellitus
New therapy using your own fat cells to treat Type 2 Diabetes
Plain English Summary
Autologous SVF Therapy for Type 2 Diabetes is a Not Applicable clinical trial sponsored by Kaiser Clinic and Hospital studying Diabetes Mellitus, Type 2. This study tests a new way to treat Type 2 Diabetes using a patient's own fat-derived cells. It is for adults with Type 2 Diabetes who have had the condition for less than 10 years and have specific blood sugar levels. Participation involves a procedure to collect fat, process it into a therapy, and then inject it into the digestive tract. Current alternatives include diet, exercise, oral medications, and insulin therapy. The trial aims to enroll 10 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have Type 2 Diabetes for less than 10 years, have a BMI of 25 or higher, and have an HbA1c between 7.5% and 9.5%. You must also have a certain level of a substance called C-peptide and be taking specific diabetes medications. You cannot join if you have Type 1 Diabetes, are pregnant or breastfeeding, use insulin, or are taking certain other diabetes medications like SGLT2 inhibitors or GLP-1 receptor agonists. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how much your fasting blood sugar levels change over six months, indicating how well the therapy might help manage your diabetes. The specific primary outcome measures are: Change in Fasting Plasma Glucose (mg/dL) (Baseline and 6 months post-procedure). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores a novel approach to potentially improve blood sugar control and pancreatic function in Type 2 Diabetes patients, addressing a need for new treatment options. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.
Investor Insight
This trial represents an early-stage investment in regenerative medicine for diabetes, a large market, with potential for significant impact if successful, though approval probability is currently unk
Is This Trial Right for Me?
Ask your doctor about the specific procedure, potential risks, and expected recovery time. Be prepared for a procedure to collect fat, followed by an injection into your digestive tract. You will have regular check-ups for six months to monitor your blood sugar and overall health. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- BIOLOGICAL: Autologous Adipose-Derived Stromal Vascular Fraction (SVF) — 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.
Primary Outcomes
- Change in Fasting Plasma Glucose (mg/dL) (Baseline and 6 months post-procedure)
Full Eligibility 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
Trial Locations
- Kaiser Clinica, São Jose Do Rio Preto, São Paulo, Brazil
Frequently Asked Questions
What is clinical trial NCT07487467?
NCT07487467 is a Not Applicable INTERVENTIONAL study titled "Autologous SVF Therapy for Type 2 Diabetes." It is currently recruiting and is sponsored by Kaiser Clinic and Hospital. The trial targets enrollment of 10 participants.
What conditions does NCT07487467 study?
This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT07487467?
The interventions being studied include: 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.
What does Not Applicable mean for NCT07487467?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07487467?
This trial is currently "Recruiting." It started on 2025-01-20. The estimated completion date is 2026-12-31.
Who is sponsoring NCT07487467?
NCT07487467 is sponsored by Kaiser Clinic and Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07487467?
The trial aims to enroll 10 participants. The trial is currently recruiting and accepting new participants.
How is NCT07487467 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07487467?
The primary outcome measures are: Change in Fasting Plasma Glucose (mg/dL) (Baseline and 6 months post-procedure). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07487467 being conducted?
This trial is being conducted at 1 site, including São Jose Do Rio Preto, São Paulo (Brazil).
Where can I find official information about NCT07487467?
The official record for NCT07487467 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07487467. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07487467 testing in simple terms?
This study tests a new way to treat Type 2 Diabetes using a patient's own fat-derived cells. It is for adults with Type 2 Diabetes who have had the condition for less than 10 years and have specific blood sugar levels.
Why is this trial significant?
This trial matters because it explores a novel approach to potentially improve blood sugar control and pancreatic function in Type 2 Diabetes patients, addressing a need for new treatment options.
What are the potential risks of participating in NCT07487467?
Potential risks include those associated with any surgical procedure, such as bleeding or infection. Specific side effects related to the therapy are still being studied but may include digestive discomfort or changes in blood sugar levels. The long-term effects of this new treatment are not yet fully known. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07487467?
Ask your doctor about the specific procedure, potential risks, and expected recovery time. Be prepared for a procedure to collect fat, followed by an injection into your digestive tract. You will have regular check-ups for six months to monitor your blood sugar and overall health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07487467 signal from an investment perspective?
This trial represents an early-stage investment in regenerative medicine for diabetes, a large market, with potential for significant impact if successful, though approval probability is currently unk This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves a procedure to collect fat, process it into a therapy, and then inject it into the digestive tract. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.