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

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ClinicalTrials.gov Identifier: NCT03514537

Recruitment Status : Enrolling by invitation

First Posted : May 2, 2018

Last Update Posted : March 26, 2020

Sponsor:

Collaborators:

Micheal Nissenbaum, MD

Terry, Glenn C., M.D.

Information provided by (Responsible Party):

Robert W. Alexander, MD, FICS, Healeon Medical Inc

Tracking Information

First Submitted Date ^ICMJE

March 26, 2018

First Posted Date ^ICMJE

May 2, 2018

Last Update Posted Date

March 26, 2020

Actual Study Start Date ^ICMJE

March 15, 2018

Estimated Primary Completion Date

March 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Changes in Weight In Pounds [ Time Frame: Baseline and 6 months ]
Baseline values at 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
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
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
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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Isolation and concentration of cSVF will be documented.

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

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

Condition ^ICMJE

Frail Elderly Syndrome
Aging
Degenerative Disease

Intervention ^ICMJE

Procedure: Microcannula harvest adipose stromal tissues
Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells
Device: Centricyte 1000
Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
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: Liberase
Liberase TM for use to enzymatically isolate cellular stromal vascular fraction
Drug: Saline Solution
Sterile, Normal Saline 500 for Intravenous use

Study Arms ^ICMJE

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

Intervention: Procedure: Microcannula harvest adipose stromal tissues
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
Interventions:
- Device: Centricyte 1000
- Drug: Liberase
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.
Interventions:
- Procedure: Sterile Normal Saline IV Deployment of cSVF
- Drug: Saline Solution

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

200

Original Actual Enrollment ^ICMJE

300

Estimated Study Completion Date ^ICMJE

January 15, 2024

Estimated Primary Completion Date

March 15, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

40 Years to 90 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03514537

Other Study ID Numbers ^ICMJE

GARM-Frailty

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Responsible Party

Robert W. Alexander, MD, FICS, Healeon Medical Inc

Study Sponsor ^ICMJE

Healeon Medical Inc

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Michael Nissenbaum, MD

Healeon Medical

PRS Account

Healeon Medical Inc

Verification Date

March 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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