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

NCT ID: NCT03514537

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2028-01-15

Brief Summary

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

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).

Conditions

Frail Elderly Syndrome; Aging; Degenerative Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipoaspiration

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

Group Type: EXPERIMENTAL

Microcannula harvest adipose stromal tissues

Intervention Type: PROCEDURE

Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells

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

Group Type: EXPERIMENTAL

Centricyte 1000

Intervention Type: DEVICE

Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature

Liberase

Intervention Type: DRUG

Liberase TM for use to enzymatically isolate cellular stromal vascular fraction

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.

Group Type: EXPERIMENTAL

Sterile Normal Saline IV Deployment of cSVF

Intervention Type: PROCEDURE

Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery including 150 micron in-line filtration

Saline Solution

Intervention Type: DRUG

Sterile, Normal Saline 500 for Intravenous use

Interventions

Microcannula harvest adipose stromal tissues

Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells

Intervention Type: PROCEDURE

Centricyte 1000

Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature

Intervention Type: DEVICE

Sterile Normal Saline IV Deployment of cSVF

Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery including 150 micron in-line filtration

Intervention Type: PROCEDURE

Liberase

Liberase TM for use to enzymatically isolate cellular stromal vascular fraction

Intervention Type: DRUG

Saline Solution

Sterile, Normal Saline 500 for Intravenous use

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Micheal Nissenbaum, MD

UNKNOWN

Sponsor Role: collaborator

Terry, Glenn C., M.D.

INDIV

Sponsor Role: collaborator

Healeon Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Robert W. Alexander, MD, FICS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Nissenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Healeon Medical

Locations

Fanny Island Campus Medical Building

Colchester, Vermont, United States

Countries

United States

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Other Identifiers

GARM-Frailty

Identifier Type: -

Identifier Source: org_study_id