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.
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;
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;
Parallel
Tissue Stromal Vascular Fraction (tSVF) Arm 1
Procedure/SurgeryHarvesting subcutaneous tSVF with sterile, disposable microcannula system
PRP Concentrate Arm 1
Biological/VaccinePreparation of PRP Concentrate via sterile Terumo-Harvest System
Tissue Stromal Vascular Fraction (tSVF) Arm 2
Procedure/SurgeryHarvesting subcutaneous tSVF with sterile, disposable microcannula system
PRP Concentrate Arm 2
Biological/VaccinePreparation of PRP Concentrate via sterile Terumo-Harvest System
Cellular Stromal Vascular Fraction (cSVF) Arm 2
Procedure/SurgeryIsolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Cellular Stromal Vascular Fraction (cSVF) Arm 3
Procedure/SurgeryIsolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Sterile Normal Saline (IV Solution)
DrugSuspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
Participant with Complications
Adverse and Severe Adverse Events
Numeric Pain Rating Scale (NPRS)
Subjective Pain Rating
Changes from Baseline visual analog pain scale (VAS)
Patient Reported Pain (1-10)
Changes in Ultrasound Images from Baseline Condition
High Definition Ultrasonography Soft and Hard Tissues of Musculoskeletal Areas To Be Treated
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measure Knee and OA Status for Pain and OA
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measure Change from Baseline of Pain and Arthritis In Knee and Hip
Hip Disability and OA Outcomes Survey (HOOS)
Measure Change from Baseline of Pain \& Function of Hip
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Measure Change from Baseline of Pain, Range of Motion and Function All Areas
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