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OsteoarthritisPainProcedureBiologicalDrug

What this study is

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.

What's being tested

  • Tissue Stromal Vascular Fraction (tSVF) Arm 1

    Intervention · PROCEDURE

  • PRP Concentrate Arm 1

    Intervention · BIOLOGICAL

  • Tissue Stromal Vascular Fraction (tSVF) Arm 2

    Intervention · PROCEDURE

  • PRP Concentrate Arm 2

    Intervention · BIOLOGICAL

  • Cellular Stromal Vascular Fraction (cSVF) Arm 2

    Intervention · PROCEDURE

  • Cellular Stromal Vascular Fraction (cSVF) Arm 3

    Intervention · PROCEDURE

  • Sterile Normal Saline (IV Solution)

    Intervention · DRUG

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

Both Tissue Stromal Vascular Fraction (tSVF) Arm 1 and Tissue Stromal Vascular Fraction (tSVF) Arm 2

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

Both PRP Concentrate Arm 1 and PRP Concentrate Arm 2

Preparation of PRP Concentrate via sterile Terumo-Harvest System

Both Cellular Stromal Vascular Fraction (cSVF) Arm 2 and Cellular Stromal Vascular Fraction (cSVF) Arm 3

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

Study details

Official title
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Sponsor
Healeon Medical Inc
Conditions
Osteoarthritis · Osteo Arthritis Knee · Osteo Arthritis Shoulders · Osteoarthritis of Multiple Joints · Osteoarthritis, Hip · Osteoarthritis - Ankle/Foot
Enrolling
100 people
Starts
2020-01-10
Est. completion
2027-09-30
Design
Open-label, non-randomized, parallel groups
Record
View on ClinicalTrials.gov ↗