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The ACTiVION-I study is an osteoarthritis (OA) clinical trial for adults over 40 years of age who have been diagnosed with OA in at least one knee. This study is seeking participants with knee pain caused by primary OA or “wear-and-tear” OA. The study will evaluate how well the investigational study therapy works as a potential treatment in decreasing knee pain and improving knee function in people who have mild to moderate OA of the knee.
If you qualify and choose to join the ACTiVION-I clinical trial, you may be compensated for your time and reimbursed for travel. Additionally, you will receive possible access to a new investigational therapy, study support and monitoring by a healthcare team, education about OA, and the opportunity to advance OA research, all at no cost.
If you are experiencing knee and joint pain due to osteoarthritis, you may be able to join the ACTiVION-I clinical trial if you meet the following requirements:
* Other study requirements will apply
Participation in the ACTiVION-I clinical trial lasts about 24 months and is divided into 3 periods with a long-term safety follow-up study:
Participation in this clinical trial is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study therapy (TG-C) has a mixture of human chondrocyte cells and irradiated, transduced GP2-293 cells that are injected into the knee. The intended goal of this investigational therapy is to reduce pain and delay the progression of the disease through slowing cartilage degeneration.
The investigational 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.
Participants will be randomized at a 2:1 ratio, where:
Osteoarthritis is considered a chronic (long-lasting) disease, and other than joint replacement surgery, there is presently no cure.
Non-operative treatment can be effective if subjects are compliant with the treatment plan, which typically consists of self-management activities, including, but not limited to, weight loss (when necessary), exercise, and appropriate use of anti-inflammatory medication. When self-management becomes insufficient, multiple injections may be administered. Finally, if symptoms persist, surgical treatments and ultimately knee arthroscopy or arthroplasty may be recommended.
The investigational study therapy (TG-C) in ACTiVION-I is designed as a single-dose investigational therapy in subjects with a mild to moderate osteoarthritis of the knee. The intended goal of this investigational therapy is to reduce knee pain and delay the progression of the disease through slowing the loss of knee cartilage.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the ACTIVION-I study.
Osteoarthritis (OA) is the most common form of arthritis. It is a disease that affects all the tissues of the joint, including the cartilage, bone, ligaments, and muscles. It can develop in any number of joints, but most commonly affects the knees, hands, and hips. The symptoms of OA can vary in severity, but in its more severe forms OA is a painful condition that restricts mobility, interrupts sleep, and interferes with the sufferer’s enjoyment of life. OA of the knee is characterized by pain, swelling, and stiffness resulting from cartilage damage/loss in the joint. . There are several risk factors associated with the development of OA, but it is most often caused by natural "wear-and-tear” of the knee joint over time.
OA is considered a chronic (long-lasting) disease and other than joint replacement surgery there is presently no cure.
Symptoms can occur in episodes or consistently and can turn simple daily tasks into difficult ones. These symptoms often develop slowly and worse over time. Symptoms of osteoarthritis of the knee include but are not limited to:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time for any reason.
If you have additional questions about participating in a clinical research study, talk to your doctor.
The ACTiVION-I clinical trial currently has multiple doctors across the US now accepting participants to help identify a new potential treatment for people suffering with knee pain from mild to moderate osteoarthritis of the knee. If you'd like to learn more or are interested in participating in the ACTiVION-I trial, click below to fill out a brief questionnaire and get matched to the study clinic closest to