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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
 (submitted: April 20, 2018)
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
 (submitted: April 20, 2018)
  • 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

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  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
 (submitted: January 19, 2020)
200
Original Actual Enrollment  ICMJE
 (submitted: April 20, 2018)
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