Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Healeon Medical Inc
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.
Description
Osteoarthritis (OA) is one of the most common chronic health conditions and a leading cause of pain and disability in the world, with a substantial proportion of adults affected. It is estimated that symptomatic OA affects one in eight men and women in the US (27-31 million), In a global study of health conditions, osteoarthritis and musculoskeletal pain ranked in the top 4 percent of worldwide disabilities. OA is a complex, multifactorial disease, with much still to learn regarding mechanisms and progression. . The most commonly affected joints include the hip , knee , hand and foot , and spi…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR); * No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures; * Have the ability to understand and accept all items in Informed Consent Document; * Have adequate perivascular and extracellular matrix donor tissues available; * Mature enough to tolerate determined procedures a…
Interventions
- ProcedureTissue Stromal Vascular Fraction (tSVF) Arm 1
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
- BiologicalPRP Concentrate Arm 1
Preparation of PRP Concentrate via sterile Terumo-Harvest System
- ProcedureTissue Stromal Vascular Fraction (tSVF) Arm 2
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
- BiologicalPRP Concentrate Arm 2
Preparation of PRP Concentrate via sterile Terumo-Harvest System
- ProcedureCellular Stromal Vascular Fraction (cSVF) Arm 2
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
- ProcedureCellular Stromal Vascular Fraction (cSVF) Arm 3
Locations (2)
- Hemwall Center for Orthopedic Regenerative MedicineValencia, California
- Regenevita LLCStevensville, Montana