TissueGene

Stem Cell Injection Therapy for Osteoarthritis of the Knee

To Learn More, Call:

310-358-5757, Ext.120

Or Email:

Do you have osteoarthritis of the knee?

About This Study

This study will look at how well a new study therapy works at addressing some of the symptoms of OA. 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 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: Be randomly assigned to receive the study therapy or placebo. Then, 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.

Qualified participants will receive at no cost:

· Study-related lab tests and physical exams

· New study therapy or placebo (no active ingredients)

· Participants will be twice as likely to receive the study drug as the placebo

· Education about OA

To learn more, please contact our study coordinators!

Do you qualify?

Are you over 40 years old?
Have you ever been diagnosed with chronic osteoarthritis of the knee?
Are you able to bear weight on your knee without severe pain or the use of a cane, crutch, walker, etc.? [ If yes, see below. ]

Have you received any injections in your knee with osteoarthritis within the last 2 months or had surgery on this knee in the last 6 months?
Have you had any major injuries to the knee in the last year?
Do you have severe osteoarthritis of the hip on the same side as this knee?
Are you taking any of the following types of medications?
- local or systemic steroidal anti-inflammatory medications, biologic therapy medications, opiates and/or oxycodone, narcotic treatment, anti-platelet drugs, or anti-coagulants
Do you suffer from any of the following conditions?
- rheumatoid arthritis, psoriatic arthritis, fibromyalgia, gout, congestive heart failure Class II or greater, acute or chronic hepatic disease, chronic kidney disease, hyper or hypothyroidism, uncontrolled diabetes, or active cancer?
- infectious disease such as HIV, HTLV-1, VSV-G, HBV, or HCV?
- genetic mutations including, but not limited to, BRCA 1/2, Lynch syndrome, Cowden syndrome, Li Fraumeni syndrome, Von Hippel-Lindau disease, multiple endocrine neoplasia, Crohn's disease, ulcerative colitis, multiple sclerosis, or other known conditions with predispositions for higher risk of cancer?

If not, you may be eligible for this study.

Submission of prior x-ray or MRI imaging may expedite the screening process. Please contact our study coordinators to learn more!

Email: nicolettec@omcresearch.org

Call +1 (310) 358-5757