What side effects are associated with this type of intervention?

The most common treatments for Frailty Syndrome that involve regenerative and anti-inflammatory properties, such as autologous cellular stromal vascular fraction (cSVF), mesenchymal stem cells (MSCs), and platelet-rich plasma (PRP), generally have a favorable safety profile. However, they can still cause side effects. These may include local pain, bleeding, tenderness, swelling, and bruising at the injection site. There is also a risk of infection associated with any injection-based therapy. In some cases, patients may experience fatigue, diarrhea, or other systemic effects. It is important to carefully weigh the benefits and risks of these treatments with a healthcare provider.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs or treatments explicitly for Frailty Syndrome. However, treatments that focus on regenerative and anti-inflammatory properties, such as the use of autologous cellular stromal vascular fraction (cSVF), are being studied. These treatments aim to improve the quality of life and functional health in aging populations by leveraging the body's own cells to promote healing and reduce inflammation. While promising, these therapies are still largely in the experimental stage and have not yet received FDA approval for the treatment of Frailty Syndrome.

What other types of research exist?

Promising alternatives to cSVF for frailty syndrome patients include: 1) Intravenous infusion of allogenic mesenchymal stem cells (MSCs), which have shown safety, tolerability, and preliminary clinical efficacy. 2) Embryonic stem cell-derived extracellular vesicles (ES-EVs), which have demonstrated rejuvenating effects on senescent MSCs and improved therapeutic outcomes in preclinical models.

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Stem Cell Therapy

cSVF Therapy for Frailty Syndrome (GARM-W Trial)

N/A

Waitlist Available

Led By Michael Nissenbaum, MD

Research Sponsored by Healeon Medical Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the fat tissue removal site such as pain or bruising; complications related to IV infusion like infection; allergic reactions to enzymes used during cell processing; and general risks associated with any invasive procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Activity Level

Changes in Weight In Pounds

Fatigue

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: LipoaspirationExperimental Treatment1 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 cSVFExperimental Treatment2 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 IntravenousExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saline Solution

2016

Completed Phase 4

~4980

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Frailty Syndrome, such as autologous cellular stromal vascular fraction (cSVF), work primarily through regenerative and anti-inflammatory mechanisms. cSVF is derived from a patient's own adipose tissue and contains a mixture of stem cells, growth factors, and cytokines. These components help to repair and regenerate damaged tissues, reduce inflammation, and improve overall cellular function. For patients with Frailty Syndrome, these treatments are crucial as they can enhance physical function, increase strength, and improve quality of life by addressing the underlying cellular and tissue damage associated with aging.

Mesenchymal stem cell treatment improves outcome of COVID-19 patients via multiple immunomodulatory mechanisms.Extracellular vesicles from mesenchymal stromal cells: Therapeutic perspectives for targeting senescence in osteoarthritis.Alterations in IL-6/STAT3 Signaling by Korean Mistletoe Lectin Regulate the Self-Renewal Activity of Placenta-Derived Mesenchymal Stem Cells.