TissueGene Study
The Ainsworth Institute of Pain Management has been selected for a new FDA Clinical Trial for Knee Pain. This study will evaluate an extremely unique stem cell line specifically developed to repair arthritic joints – in particular, the knee. We are one of just a handful of sites throughout the country selected to participate in this study.
Arthritis is a general term used to describe joint pain – the actual definition is inflammation of a joint. There are many different types of arthritis, the most common being osteoarthritis (OA). In basic terms, OA is a condition that arises when the cushioning cartilage of a joint wears away and the bony surfaces of the joint begin to rub against one another. This leads to an inflammatory process in the joint that causes the joint to swell and become increasingly painful.
Ultimately, the damage become irreversible and the goal is to simply manage the pain as best as possible…
Knee Pain
The knee is the largest moveable joint in the human body, and also one of the most complex. It connects your femur (thigh bone) to your tibia and fibula (leg bones). The knee is also very vulnerable and easily injured, which can lead to pain. Knee pain is extremely common and can affect people of all ages. It may begin suddenly after an injury or exercise, or start to hurt gradually and worsen over time from basic wear & tear. Your knees spend most of their life bearing the weight of your entire body. If they are injured, it can lead to constant pain.
Traditionally, the treatments for OA of the knee are very limited:
This study is a prospective, multicenter clinical trial comparing the efficacy of a particular strain of cell cells known as “Juvenile Chrondrocytes” to an injection of saline into the knee.
Juvenile Chondrocytes have been genetically engineered to suppress inflammation and regrow cartilage within a painful, arthritic knee – effectively regenerating the knee. Most stem cell treatments currently available are crude and typically administered by individuals who learned about stem cell therapy by taking a weekend course. This study is being conducted at only a handful of site around the country specifically handpicked for their expertise in both knee pain and stem cell therapy.
This study could change the face of medicine as we know it!
Stem cell therapy for pain is currently considered experimental in the United States and is not covered by any insurance companies at present. If this study is successful, it could become a covered treatment under Medicare. There is no cost to participate in this study if you qualify and are chosen to participate.
THIS STUDY IS ACTIVELY RECRUITING PATIENTS AS OF March 4th, 2022
Can I Participate in this Study?
Details of the Study
Patients who qualify for the study will be randomized to receive either a saline injection into the painful knee or injection of stem cells. Subjects will then be expected to follow up every couple of months out to 24-months. This will include periodic MRI’s and blood tests – all of which are paid for 100% by the study sponsor.
Study Enrollment Form
Official Protocol Name: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.
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