cSVF Therapy for Frailty Syndrome

(GARM-W Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Healeon Medical Inc

Disqualifiers: Neurodegenerative disorder, Uncontrollable hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve the quality of life and functional health in older adults by using their own fat-derived cells. These cells are taken from the body, processed, and then reintroduced. The goal is to see if this method is safe and effective in helping with age-related health issues.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) for Frailty Syndrome?

Research on similar treatments, like mesenchymal stem cells (MSCs), shows they are safe and may help improve frailty symptoms by enhancing the body's ability to repair itself. These studies suggest that using stem cells can be a promising way to address frailty, although more research is needed to confirm their effectiveness. ^{1 2 3 4 5}

Is cSVF therapy safe for humans?

Research on similar stem cell therapies, like mesenchymal stem cells (MSCs), suggests they are generally safe and well-tolerated in humans, with studies focusing on frailty showing no major safety concerns. ^{1 2 3 6 7}

How is cSVF therapy different from other treatments for frailty syndrome?

cSVF therapy is unique because it uses a patient's own stem cells, extracted from fat tissue, to potentially regenerate and repair damaged tissues. This approach is different from traditional treatments as it involves using the body's natural healing processes rather than relying on medications or supplements. ^{8 9 10 11 12}

Research Team

Michael Nissenbaum, MD

Principal Investigator

Healeon Medical

Eligibility Criteria

This trial is for people aged 40-90 who feel weaker and less able to exercise over the last six months, can walk a certain distance in six minutes, and are willing to consent. It's not for those with uncontrolled high blood pressure, recent drug or alcohol abuse, very short life expectancy, severe neurodegenerative diseases that affect walking tests, poor mental function scores on MMSE, certain cancers within 2 years (except some skin lesions), abnormal blood values or serious co-morbidities.

Inclusion Criteria

Be >40 and <90 years of age and willing and able to provide written informed consent

Those aging and frail patients who have noted compromise to activities or work requirements due to increasing age

Current clinical history of malignancy within 3 years, except for curable skin lesions including basal cell carcinoma, or squamous cell carcinoma

Exclusion Criteria

You have a life expectancy of less than 6 months.

You have a serious brain condition that would make it difficult to understand or measure the study results.

Systemic disorders that preclude completion of the testing or out of medical management control in the opinion of the PIs or Primary Care Provider

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lipoaspiration

Closed microcannula harvesting of small volume of subdermal adipose tissue, including the stromal cellular and stromal tissue using sterile, disposable, microcannula system

1 day

1 visit (in-person)

Isolation & Concentration of cSVF

Isolation and Concentration of cellular stromal vascular fraction (cSVF) using a Healeon Medical CentriCyte 1000 centrifuge, incubator and shaker plate with sterile Liberase enzyme

1 day

1 visit (in-person)

Treatment

Delivery of cSVF via intravenous infusion with 500cc Normal Saline over 30-60 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF)

Trial Overview The trial is testing if injecting patients' own processed fat tissue cells back into their bloodstream can improve quality of life and health in aging. Fat tissue is taken from the patient's body using a special technique called Microcannula harvest adipose stromal tissues. The cells are then isolated with an enzyme digestion system before being returned via IV.

Participant Groups

Group I: Lipoaspiration Experimental Treatment 1 Intervention

Closed microcannula harvesting of small volume of subdermal adipose tissue, including the stromal cellular and stromal tissue using sterile, disposable, microcannula system

Group II: Isolation & Concentration of cSVF Experimental Treatment 2 Interventions

Isolation and Concentration of cellular stromal vascular fraction (cSVF) using a Healeon Medical CentriCyte 1000 centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols

Group III: Delivery cSVF via Intravenous Experimental Treatment 2 Interventions

cSVF from Arm 2 is suspended in a 500cc of sterile Normal Saline and deployed through 150 micron in-line filtration and intravenous route over 30-60 minute time frame.

Who Is Running the Clinical Trial?

Healeon Medical Inc

Lead Sponsor

Trials

9

Recruited

710+

Micheal Nissenbaum, MD

Collaborator

Trials

1

Recruited

200+

Terry, Glenn C., M.D.

Collaborator

Trials

5

Recruited

460+

Findings from Research

In a study involving 421 patients, the administration of autologous stromal vascular fraction (SVF) mixed with platelet-rich plasma (PRP) was found to be safe, with no major adverse events reported, even at doses up to 10 billion SVF cells for intravenous injections.

Adverse events were minor and primarily associated with spinal or intra-articular injections, indicating that the SVF and PRP themselves were not responsible for these issues, suggesting a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. Karina, K., Rosliana, I., Rosadi, I., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Frailty and Rejuvenation with Stem Cells: Therapeutic Opportunities and Clinical Challenges. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Attenuation of frailty in older adults with mesenchymal stem cells. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells for Frailty? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical Study of Mesenchymal Stem/Stromal Cell Therapy for the Treatment of Frailty: A Proposed Experimental Design for Therapeutic and Mechanistic Investigation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cell Therapy for Aging Frailty. [2021]

8. Egypt pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Assessment of safety and efficacy of intra-articular injection of stromal vascular fraction for the treatment of knee osteoarthritis-a systematic review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Comparison of Microfat, Nanofat, and Extracellular Matrix/Stromal Vascular Fraction Gel for Skin Rejuvenation: Basic Animal Research. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The ratio of ADSCs to HSC-progenitors in adipose tissue derived SVF may provide the key to predict the outcome of stem-cell therapy. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Autologous and heterotopic transplantation of adipose stromal vascular fraction ameliorates stress urinary incontinence in rats with simulated childbirth trauma. [2022]