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

Sponsor
Healeon Medical Inc (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03514537
Collaborator
Micheal Nissenbaum, MD (Other), Terry, Glenn C., M.D. (Other)
200
Enrollment
1
Location
3
Arms
70
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Microcannula harvest adipose stromal tissues
  • Device: Centricyte 1000
  • Procedure: Sterile Normal Saline IV Deployment of cSVF
  • Drug: Liberase
  • Drug: Saline Solution
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 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 :
Mar 15, 2018
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [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 [Baseline and 6 months]

    Baseline values at baseline and 6 months;

  2. Activity Level [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Michael Nissenbaum, MD, Healeon Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Robert W. Alexander, MD, FICS, Principal Investigator, Healeon Medical Inc
ClinicalTrials.gov Identifier:
NCT03514537
Other Study ID Numbers:
  • GARM-Frailty
First Posted:
May 2, 2018
Last Update Posted:
Mar 26, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Frailty

Study Results

No Results Posted as of Mar 26, 2020