Clinical trial NCT03514537: Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Frailty-Aging Processes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Aging
Degenerative Disease
Lead sponsor: Healeon Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Micheal Nissenbaum, MD
name: Terry, Glenn C., M.D.
First posted: 2018-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Weight In Pounds
timeFrame: Baseline and 6 months
measure: Activity Level
timeFrame: baseline and 6 months
measure: Mobility
timeFrame: baseline and 6 months
measure: Fatigue
timeFrame: baseline and 6 months
measure: Mobility Performance Battery
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Colchester
country: United States
facility: Fanny Island Campus Medical Building
state: Vermont
Study officials:
affiliation: Healeon Medical
name: Michael Nissenbaum, MD
role: PRINCIPAL_INVESTIGATOR
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