Pending Institutional Review Board (IRB) approval, Global Stem Cells Group, Inc. has announced plans to conduct a multi-centre, placebo controlled clinical trial to measure the safety and effectiveness of the intra-articular application of freshly isolated bone marrow stem cells for the treatment of osteoarthritis.
The clinical trials, which will begin July 1, 2016 and run for one year, will be held in Global Stem Cell Group facilities in Buenos Aires, Argentina; Bogota, Colombia; Quito, Ecuador; Miami, Florida and Topeka, Kansas. Each centre will accept 25 patients per clinical trial, and patients will receive a bone marrow stem cell injection in one knee and a placebo in the other knee..
The trials are designed to investigate the possible beneficial effect of freshly harvested bone marrow stem cell applications on knee osteoarthritis patients in the control group. Patients will receive standard treatment of bone marrow stem cells intravenously, and will be monitored and assessed for any changes in clinical condition.
Knee osteoarthritis is a chronic, progressive condition affecting an increasing number of people, especially the elderly and obese. It is characterized by degeneration of the cartilage—the natural cushioning between joints inside the knee.
The condition is the result of the wearing away of cartilage. When this happens, the bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage, resulting in pain, swelling, stiffness and a decreased ability to move.
According to the Centers for Disease Control (CDC), knee osteoarthritis will affect 67 million people in the United States by 2030. While conventional treatments like physiotherapy or drugs offer temporary relief of clinical symptoms, total knee replacement is the closest treatment available for permanent relief, which requires invasive surgery, comes at a high cost and is not always successful. The latest advances in stem cell therapies for knee osteoarthritis are designed to restore cartilage function in the knee.
Global Stem Cells Group offers the most advanced protocols and techniques in cellular medicine from around the world.
Details of the protocol and eligibility criteria will be released upon IRB approval.
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