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 range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Hemoglobin values \<11 g/dL
. Pregnant or breastfeeding women
. 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.