Osteoarthritis of the Knee - Brooklyn NY

Summary:

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 a placebo, which has no active ingredients.

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 knee function. 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.

The ACTiVION-II study will last for about 24 months, divided into 3 periods:
Screening
Receive tests and assessments to confirm you qualify for the study, including blood and urine tests,
imaging 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 tests and assessments. 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 to 14 years. If you do not want to participate in the Long-Term Follow-up study, then you will be asked to answer questions about your health for 13 years.

You may qualify for the study if you meet the following requirements:

• Are 40 years of age or older
• Have OA symptoms of a certain severity
• You will be asked to rate your pain, mobility, and other symptoms during the Screening

Note: additional criteria apply.

If you qualify, you may also be invited to participate in a Long-Term Follow-up study of 15 years. If you choose not to participate in
this study, you will be contacted once a year for 13 years to answer a questionnaire about your health.

Qualified Participants May Receive:

There will be no cost to you or your insurance company for the study treatment or the study-related procedures and examinations.

For your time and inconvenience related to your participation in this study, you will be paid for the study visits you complete according to the following schedule: $150 for completed office visits and $200 for MRI visits. If you do not complete the study for any reason, you will be paid for each study visit you do complete according to the schedule above.
You will be paid after each visit.