APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee (NCT02210468) | Clinical Trial Compass
UnknownPhase 1/2
APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee
United States300 participantsStarted 2015-05
Plain-language summary
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.
Who can participate
Age range21 Years – 70 Years
SexALL
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Inclusion criteria
✓. The patient provides signed written informed consent
✓. The patient is willing and able to complete effectiveness and safety questionnaires and is able to read and understand study instructions in English.
✓. Patient is a male or female aged between 21 - 70 years of age at the time of informed consent.
✓. Patient is ambulatory (assistive devices allowed if used 4 weeks or more prior to Screening).
✓. Patient has symptomatic OA in the target knee
✓. Patient has a radiographic confirmation of OA at the target knee prior to screening with a grade II or III score on the K-L grading scale (Kellgren, 1957)using radiographs performed within 24 weeks of Screening
✓. The patient has knee pain as demonstrated by a score of ≤3 on the KOOS pain subscale
✓. The patient has venous access sufficient for APIC-CF production
Exclusion criteria
✕. The patient has any of the following:
✕. Medical history of severe bone disease (e.g., osteoporosis, osteonecrosis, joint deformity, instability, or septic arthritis).
✕. The patient is categorized as grossly obese, defined as body mass index (BMI) greater than 35 kg/m2
✕. Has clinically apparent tense effusion of the target knee.
✕. Has had chondrocyte transplantation or reconstruction of ligaments in the target knee.
✕. Has received an intra-articular injection(s) into any joint (e.g., corticosteroids or chondroprotective agents) within 60 days prior to Screening. Subjects receiving a corticosteroid injection during the study will be withdrawn from the study.