The mechanism of Osteoarthritis (OA) is complex, however the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that use the patient's own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
IRC Clinical
Townsend, Maryland, United States
RECRUITINGReduction in pain after 8 weeks
Statistically significant reduction in pain after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Time frame: 8 weeks
Reduction in pain while walking at 8 weeks
Statistically significant reduction in pain while walking after 8 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Time frame: 8 weeks
Reduction in pain after 2 weeks
Statistically significant reduction in pain after 2 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score.
Time frame: 2 weeks
Reduction in pain while walking at 2 weeks
Statistically significant reduction in pain while walking after 2 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Time frame: 2 weeks
Reduction in pain at 24 weeks
Statistically significant reduction in pain after 24 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
Time frame: 24 weeks
Reduction in pain while walking after 24 weeks
Statistically significant reduction in pain while walking after 24 weeks from initial treatment of APIC-CF compared to control as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) total score
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Time frame: 24 week