The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
San Diego Orthobiologics Medical Group
Carlsbad, California, United States
Grossmont Orthopedic Medical Group
La Mesa, California, United States
Synergy Orthopedic Specialists Medical Group
San Diego, California, United States
The Orthohealing Center
Santa Monica, California, United States
Incidence of Adverse Events
The primary outcome measure of this study is to evaluate the safety of the investigational biological product, PSC-01.Safety will be assessed as the number of treatment-related adverse events as assessed by CTCAE v5.0. Adverse events will be assessed by physical examination, patient-reported health status, clinical pathology evaluations (cbc, chemistry, and urinalysis), and post-procedure clinical observations through the 84-day study period with post-treatment follow-up at 6 and 12 months.
Time frame: 3-4 months
Changes in KOOS Measurement
The secondary outcome measure of this study is to obtain initial data on the efficacy of PSC-01 on treating knee osteoarthritis. The efficacy primary outcome will be assessed using the KOOS knee survey with the five relevant subcategories of pain, symptoms, average daily living, sport/recreation, and quality of life measured at baseline, day 42 and day 84.
Time frame: 3-4 months
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Cellular Orthopedics
Des Plaines, Illinois, United States
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, United States
RestorePDX
Beaverton, Oregon, United States