Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA) (NCT06123689) | Clinical Trial Compass
WithdrawnNot Applicable
Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)
Stopped: Sponsor decision
0Started 2024-03-01
Plain-language summary
The goal of this clinical trial is to compare in 60 patients suffering for Knee OA to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].
Researchers will compare 2 Groups to see to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate to pain management and improvement of functionality.
Who can participate
Age range
25 Years – 65 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
. Male or female age 25-65 inclusive with open physis confirmed by MRI (Size of the articular cartilage lesion is ≥ 2 cm2)
. Documented symptomatic stable diagnosed degenerative knee chondropathy from grade II to III based on MRI without changes of osteoarthritis and no prior history of knee surgery. The MRI diagnosis must be within a 3-month time period prior to consent.
. Joint pain: 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
. The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
. Body Mass Index (BMI) ≤ 30 kg/m2 (extremely obese)
. No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
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.