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

Aging Clinical Trial

— GARM-W  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03514537
• Other study ID #: GARM-Frailty
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: January 15, 2024

Study information

• Verified date: March 2020
• Source: Healeon Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 15, 2024
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Degenerative Disease
• Frail Elderly Syndrome
• Frailty

Intervention

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
• Saline Solution
Sterile, Normal Saline 500 for Intravenous use

Locations

Country	Name	City	State
United States	Fanny Island Campus Medical Building	Colchester	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
Healeon Medical Inc	Micheal Nissenbaum, MD, Terry, Glenn C., M.D.

Country where clinical trial is conducted

United States, 

References & Publications (33)

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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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Number of Participants with Treatment Related Adverse & Severe Adverse Events Assessed By CTCAE v4.0	6 months
Secondary	Changes in Weight In Pounds	Baseline values at baseline and 6 months;	Baseline and 6 months
Secondary	Activity Level	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	baseline and 6 months
Secondary	Mobility	4 meter gait speed test and short physical performance battery (SPPB); Score of <10 at baseline to predict ability to walk 400 meters	baseline and 6 months
Secondary	Fatigue	Multidimensional Fatigue Inventory Questionnaire (MFI); 20 Item self-reporting general fatigue, mental fatigue, reduced motivation, reduced activity levels	baseline and 6 months
Secondary	Mobility Performance Battery	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)	baseline and 6 months