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

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

Conditions

• Frail Elderly Syndrome
• Aging
• Degenerative Disease

Interventions

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

DRUG

Saline Solution

Sterile, Normal Saline 500 for Intravenous use

Sponsors & Collaborators

• Micheal Nissenbaum, MD

  collaborator UNKNOWN

• Terry, Glenn C., M.D.

  collaborator INDIV

• Healeon Medical Inc

  lead INDUSTRY

Principal Investigators

• Michael Nissenbaum, MD · Healeon Medical

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-15

Primary Completion

2027-03-15

Completion

2028-01-15

FDA Device

Yes

Countries

• United States

Study Locations