ACTIVION-II
This study will look at how well an investigational study therapy works at addressing some of the symptoms of osteoarthritis (OA) of the knee. Investigational means the study therapy has not been approved by any regulatory agency. Some participants will receive placebo, which has no active ingredients.
What is the study therapy?
The study therapy is a type of gene therapy, in which healthy cells that form the cartilage, called chondrocytes, are injected into the knee. These cells are designed to reduce knee pain and improve function of the knee. The study therapy will be given as an injection. A medical professional will carefully insert a needle into your knee using an imaging device to help guide them.
Who can join the study?
You may qualify for the study if you meet the following requirements:
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Are 40 years of age or older
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Have OA symptoms of certain severity
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you will be asked to rate your pain, mobility, and other symptoms during screening
Note: additional criteria apply
What can study participants expect?
The ACTIVION-II study will last for about 24 months, divided into 3 periods.
Screening
Receive tests and assessment to confirm you qualify for the study, Including blood and urine tests, Imagining tests, and questionnaires
Study Therapy
Receive your injection. you will remain at the study clinic for 2 hours afterward so the study team can check your health.
Follow-Up
Visit the study clinic for the tests and assessment. You will have visits 1 day, 1 week, and 1 month after your injection, and then 6 times over the next 24 months. you will then be asked to participate in a Long-Term Follow-Up study to monitor your progress for up tp 14 years. If you do not want to participate in th Long-Term Follow-Up study, then you will be asked to answer questions about your health for 13 years.
