Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Healeon Medical Inc
100 participants
Jan 10, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 and follow up instructions and complete post-treatment tracking responsibilities
Exclusion Criteria8
- Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
- Known active cancer, chemotherapy, or radiation therapy;
- Pregnancy;
- Active infections which would increase risk of patient to undergo treatment;
- High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
- Medication or Opiate addition, or in active treatment for drug rehabilitation;
- History of documented severe traumatic brain injuries;
- In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements
Interventions
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04238143