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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment to help people with frailty syndrome feel better and improve their daily lives. The process involves taking and concentrating cells from a person's own fat tissue, then reintroducing them into the body through an IV. This method is known as Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) therapy. The goal is to determine if this can safely boost energy levels and overall health. Suitable candidates for this trial are individuals over 40 who have experienced a decline in energy and exercise ability over the past six months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for many.

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 prior data suggests that this protocol is safe for humans?

Research has shown that using a person's own cells, called autologous stromal vascular fraction (cSVF), is generally safe. In a study with 421 patients, cSVF combined with platelet-rich plasma was well-tolerated, and most patients did not experience serious side effects.

Another safety review from several clinical sites found that cSVF taken from fat tissue is safe to use. Participants in these studies usually had only mild reactions, if any. However, a potential risk exists when cSVF is administered through an IV, as the cells might get trapped in the lungs, which could be a concern.

Overall, evidence suggests cSVF is mostly safe but does have some risks. Participants should consider these when thinking about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cSVF therapy for frailty syndrome because it uses the body's own stem and stromal cells, which could offer a more natural and potentially less invasive treatment option. Unlike traditional medications or physical therapy, cSVF involves harvesting a small amount of the patient's own fat tissue and isolating the cellular stromal vascular fraction, which is rich in regenerative cells. This approach aims to directly rejuvenate tissues and improve physical function by delivering these cells intravenously. The potential for a personalized treatment that taps into the body's natural healing capabilities sets cSVF apart from existing options.

What evidence suggests that this trial's treatments could be effective for frailty syndrome?

Research has shown that a treatment called autologous stromal vascular fraction (cSVF) might improve the quality of life for people with frailty syndrome. In a study with 421 patients, researchers found that cSVF mixed with platelet-rich plasma (PRP) was safe and showed potential benefits. Participants in this trial will receive cSVF derived from their own fat tissue, which contains cells that may help repair and regenerate tissues. Early research suggests these cells could slow down or even reverse some effects of aging. While more research is needed, these findings offer hope for improving health and function in older adults. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Nissenbaum, MD

Principal Investigator

Healeon Medical

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03514537

Study Details | NCT03514537 | Autologous Stem/Stromal ... The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve the quality of ...

2. ctv.veeva.com ctv.veeva.com/study/autologous-stem-stromal-cellular-stromal-vascular-fraction-csvf-in-frailty-aging-processes

Autologous Stem/Stromal Cellular Stromal Vascular Fraction ... The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve ...

3. withpower.com withpower.com/trial/phase-frailty-2-2018-ca29f

cSVF Therapy for Frailty Syndrome (GARM-W Trial) 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, ...

4. clinconnect.io clinconnect.io/trials/NCT03514537

Autologous Stem/Stromal Cellular Stromal Vascular The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve the quality of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116573/

Recent clinical trials with stem cells to slow or reverse ... Several clinical trials have been launched in order to evaluate the efficacy of mesenchymal stem cell interventions to slow or reverse normal aging processes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5633095/

Safety Analysis of Autologous Stem Cell Therapy in a ... In this study, we report a safety analysis of multiple clinical sites utilizing stromal vascular fraction (SVF) derived from the fat tissue for ...

7. frontiersin.org frontiersin.org/journals/aging/articles/10.3389/fragi.2023.1148926/full

Recent clinical trials with stem cells to slow or reverse ... However, intravenous administration runs the risk of entrapment of the stem cells in the lungs (and could raise safety concerns). In addition to ...