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

Healeon Medical

Status: Unknown

Conditions: Degenerative Disease; Aging; Frail Elderly Syndrome

Treatments: Procedure: Sterile Normal Saline IV Deployment of cSVF; Drug: Saline Solution; Procedure: Microcannula harvest adipose stromal tissues; Device: Centricyte 1000; Drug: Liberase

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03514537

GARM-Frailty

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Lipoaspiration

Experimental group

Description:

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

Treatment:

Procedure: Microcannula harvest adipose stromal tissues

Isolation & Concentration of cSVF

Experimental group

Description:

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

Treatment:

Device: Centricyte 1000

Drug: Liberase

Delivery cSVF via Intravenous

Experimental group

Description:

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:

Procedure: Sterile Normal Saline IV Deployment of cSVF

Drug: Saline Solution