Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Frailty-Aging Processes (GARM-W)

September 8, 2025 updated by: Robert W. Alexander, MD, FICS, Healeon Medical Inc

Use of Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Cases Of Frailty and Aging Processes Using Autologous Stem-Stromal Cell Infusion in Patients With Aging Frailty And Wellness

With increasing age and health issues associated with aging, many systemic cellular and structural changes are known to occur. 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 life and functional health.

Isolation and concentration of cSVF will be documented.

To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic digestion to isolate and concentrate these cells, is followed with returning these cSVF elements only via 500 cc Normal Saline delivered via peripheral vein (IV).

Documentation of cellular numbers and flow cytometer viability testing is to be correlated with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form tracking

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

With increasing age and health issues associated with aging, many systemic cellular and structural changes are known to occur. 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 life and functional health.

Isolation and concentration of cSVF will be documented.

To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic digestion to isolate and concentrate these cells, is followed with returning these cSVF elements only via 500 cc Normal Saline delivered via peripheral vein (IV).

Documentation of cellular numbers and flow cytometer viability testing is to be correlated with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form tracking.

Safety of use of certain allogeneic human mesenchymal stem cells (hMSC) has been tested and established along with the effectiveness of use. Autologous stem-stromal cells have been proven safe and effective in many applications and in clinical trials currently underway. These cells are easily obtained and isolated/concentrated in a closed system from patient's adipose derived stromal vascular fraction (cSVF). This is important as such tissues are uniquely the patient's cells, without the need for culture expansion of non-self human tissues, therefore potentially increasing availability to obtain non-allergenic, autologous cells known to be multipotent (can form a variety of specialized cell populations from the body) cell group within the cellular stromal vascular fraction (cSVF) present in essentially all tissues throughout the body (muscle, brain, bone, cartilage, nerve, skin, cardiac muscle, etc.).

This study seeks to determine the safety, efficiency, and in subsequent studies (phase III type) to determine optimal dosages that are needed. Delivery of the cSVF will be returned to the patient's via a standard Normal Saline intravenous infusion (IV).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Fanny Island Campus Medical Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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
  • Ability to execute a 6 minute walk test distance of >200 meters and <1000 meters
  • Loss of energy and exercise tolerance over 6 month period minimum
  • Current clinical history of malignancy within 3 years, except for curable skin lesions including basal cell carcinoma, or squamous cell carcinoma
  • Must have the ability to provide Informed Consent

Exclusion Criteria:

  • Medical conditions which prevent the ability of assessment of walk distance testing criteria
  • Have disabling neurodegenerative disorder which would impede interpretation of outcomes
  • Have a score of <24 on the Mini Mental State Examination (MMSE)
  • History of malignancy within 2 years (excluding curative skin lesion of basal cell carcinoma, melanoma-in-situ, or cervical carcinoma
  • Have clinically important abnormal screening laboratory values, including, but not limited to: Hemoglobin <10 g/dL; White blood cell count (WBC) <2500/mL; Platelet count microliters <100000/uL(microliters); Genetic Coagulopathy history
  • Uncontrollable hypertension
  • Systemic disorders that preclude completion of the testing or out of medical management control in the opinion of the PIs or Primary Care Provider
  • Expected lifespan of less that 6 months
  • Current drug abuse history < 6 months
  • Alcohol abuse within 6 months of enrollment
  • Serious or life threatening co-morbidities that in the opinion of investigators, may compromise the safety or compliance with the study guidelines and tracking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipoaspiration
Closed microcannula harvesting of small volume of subdermal adipose tissue, including the stromal cellular and stromal tissue using sterile, disposable, microcannula system
Procedure: Microcannula harvest adipose stromal tissues
Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells
Experimental: 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 (Roche Medical) per manufacturer protocols
Device: Centricyte 1000
Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
Drug: Liberase
Liberase TM for use to enzymatically isolate cellular stromal vascular fraction
Experimental: Delivery cSVF via Intravenous
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.
Procedure: Sterile Normal Saline IV Deployment of cSVF
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery including 150 micron in-line filtration
Drug: Saline Solution
Sterile, Normal Saline 500 for Intravenous use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 6 months
Number of Participants with Treatment Related Adverse & Severe Adverse Events Assessed By CTCAE v4.0
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Weight In Pounds
Time Frame: Baseline and 6 months
Baseline values at baseline and 6 months;
Baseline and 6 months
Activity Level
Time Frame: baseline and 6 months
Activity level Community Healthy Activities Model Program for Seniors (CHAMPS); Questionnaire; Self Reporting Assessment frequency and duration of various standing, walking, exercise tolerance, and changes in physical activity levels
baseline and 6 months
Mobility
Time Frame: baseline and 6 months
4 meter gait speed test and short physical performance battery (SPPB); Score of <10 at baseline to predict ability to walk 400 meters
baseline and 6 months
Fatigue
Time Frame: baseline and 6 months
Multidimensional Fatigue Inventory Questionnaire (MFI); 20 Item self-reporting general fatigue, mental fatigue, reduced motivation, reduced activity levels
baseline and 6 months
Mobility Performance Battery
Time Frame: baseline and 6 months
Short Mobility Performance Battery (SPPB) Assessment; Evaluates lower extremity function via standing balance (time), 4 meter gait speed and 5 repetition sit to stand (ability)
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healeon Medical Inc

Collaborators

Terry, Glenn C., M.D.
Micheal Nissenbaum, MD

Investigators

  • Principal Investigator: Michael Nissenbaum, MD, Healeon Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

January 15, 2028

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GARM-Frailty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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