Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

Summary

Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures.

This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.

Conditions

• Osteoarthritis
• Osteo Arthritis Knee
• Osteo Arthritis Shoulders
• Osteoarthritis of Multiple Joints
• Osteoarthritis, Hip
• Osteoarthritis - Ankle/Foot

Interventions

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 1

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 1

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 2

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 2

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 2

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 3

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

DRUG

Sterile Normal Saline (IV Solution)

Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)

Sponsors & Collaborators

• Donna Alderman, DO

  collaborator UNKNOWN

• Robert W. Alexander, MD

  collaborator UNKNOWN

• Healeon Medical Inc

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-10

Primary Completion

2026-09-30

Completion

2027-09-30

FDA Device

Yes

Countries

• United States

Study Locations