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Trial record 2 of 2 for:    21093719 [PUBMED-IDS]

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 : January 30, 2019
Sponsor:
Collaborators:
Micheal Nissenbaum, MD
Terry, Glenn C., M.D.
Information provided by (Responsible Party):
Robert W. Alexander, MD, FICS, Healeon Medical Inc

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


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Aging Degenerative Disease Procedure: Microcannula harvest adipose stromal tissues Device: Centricyte 1000 Procedure: Sterile Normal Saline IV Deployment of cSVF Drug: Liberase Drug: Saline Solution Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2023

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in Weight In Pounds [ Time Frame: Baseline and 6 months ]
    Baseline values at baseline and 6 months;

  2. 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

  3. 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

  4. 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

  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514537


Locations
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United States, Vermont
Fanny Island Campus Medical Building
Colchester, Vermont, United States, 05446
Sponsors and Collaborators
Healeon Medical Inc
Micheal Nissenbaum, MD
Terry, Glenn C., M.D.
Investigators
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Principal Investigator: Michael Nissenbaum, MD Healeon Medical

Publications:
Alexander, R. Understanding Adipose-derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components: A Concise Review. J Prolotherapy, 2012 J of Prolo (JOP) 4:e13777
Alexander, R., Understanding Mechanical Emulsification (Nanofat) Versus Enzymatic Isolation of Tissue Stromal Vascular Fraction (tSVF) Cells from Adipose Tissue: Potential Uses in Biocellular Regenerative Medicine Understanding J prolo 2016
ALEXANDER, ROBERT W., "Biocellular Regenerative Medicine: Adipose-Derived Stem/Stromal Cells & Matrix" . World Biomedical Frontiers, Section of Stem Cells, 2017 July. http://biomedfrontiers.org/stem-cells-2017-7-1.
ALEXANDER, ROBERT W., "Use of Microcannula Close Syringe System For Safe And Effective Lipoaspiration and Small Volume Autologous Fat Grafting", Am J Cosm Surg 2013, 30(2): 1-12

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Responsible Party: Robert W. Alexander, MD, FICS, Principal Investigator, Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT03514537     History of Changes
Other Study ID Numbers: GARM-Frailty
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes