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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

GARM-W Trial Summary

This trial is testing the safety and efficacy of delivering autologous cellular stromal vascular fraction (cSVF) to improve quality of life and functional health.

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.Check my eligibility

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.See study design

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.

GARM-W Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Activity Level

Changes in Weight In Pounds

Fatigue

+2 more

GARM-W 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

~5260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Healeon Medical IncLead Sponsor

8 Previous Clinical Trials

510 Total Patients Enrolled

Micheal Nissenbaum, MDUNKNOWN

Terry, Glenn C., M.D.INDIV

4 Previous Clinical Trials

260 Total Patients Enrolled

Media Library

Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03514537 — N/A

Frailty Syndrome Research Study Groups: Delivery cSVF via Intravenous, Lipoaspiration, Isolation & Concentration of cSVF

Frailty Syndrome Clinical Trial 2023: Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) Highlights & Side Effects. Trial Name: NCT03514537 — N/A

Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03514537 — N/A

Frailty Syndrome Patient Testimony for trial: Trial Name: NCT03514537 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolling for the clinical trial still open to participants?

"According to data on clinicaltrials.gov, this medical study is not presently recruiting participants as it was last updated in March 25th 2020 and posted for the first time on March 15th 2018. Nevertheless, 388 other studies are actively seeking candidates at present."

Answered by AI

Is the age restriction for this trial restricted to elderly individuals?

"This clinical trial is designed for participants aged 40 to 90. Additionally, there are 8 trials available for patients younger than 18 and 379 studies open to persons over 65 years old."

Answered by AI