The ACTiVION-II investigational study is an osteoarthritis (OA) clinical trial for people who have mild to moderate OA of the knee. The study will look at how well an investigational cell therapy works as a potential OA treatment in addressing some of the symptoms associated with OA, including knee pain and decreased function.
Study participants may be able to join the study if they meet the following requirements:
- 40 years of age or older
- Have knee OA of a certain severity
- You will be asked to rate your pain, mobility, and other symptoms during Screening
* Other study requirements will apply
Participation in the ACTiVION-II investigational study lasts about 104 weeks (24 months) and is divided into 3 periods:
1. Screening:
Receive tests and assessments to confirm you qualify for the study, including blood and urine tests, imaging (X-ray and MRI) tests, and questionnaires.
2. Study Therapy:
Receive a single injection of either the investigational study therapy or placebo (2:1 randomization ratio). You will remain at the study clinic for approximately 2 hours afterward so the study team can check your health.
3. 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.
4. Long-Term Follow-up:
You will be asked to participate in a long-term safety follow-up study to monitor your progress for up to 15 years. If you do not want to participate in the long-term safety follow-up study, then you will be asked to answer questions about your health annually for 13 years after you receive your investigational study therapy or placebo injection.
Participation in this clinical study is voluntary. You can ask any questions you have and may leave this research study at any time, for any reason.
