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

• Status: Enrolling by invitation
• Trial end date: 2024-01-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Healeon Medical Inc
• Collaborators: Micheal Nissenbaum, MD; Terry, Glenn C., M.D.

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.