Aging, Degenerative Disease, Frail Elderly Syndrome
Conditions
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).
Interventions
PROCEDUREMicrocannula harvest adipose stromal tissues
Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells
DEVICECentricyte 1000
Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery including 150 micron in-line filtration
DRUGLiberase
Liberase TM for use to enzymatically isolate cellular stromal vascular fraction
DRUGSaline Solution
Sterile, Normal Saline 500 for Intravenous use
Sponsors
Micheal Nissenbaum, MD
Terry, Glenn C., M.D.
Healeon Medical Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 6 months | Number of Participants with Treatment Related Adverse & Severe Adverse Events Assessed By CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Weight In Pounds | Baseline and 6 months | Baseline values at baseline and 6 months; |
| 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 |
| 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 |
| Fatigue | 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 | 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) |
Countries
United States
Outcome results
None listed