Clinical Assessment of Low-dose Osteoinductive Protein as a Stand-alone Regimen in Self-reported Osteoarthritis.

Arthritis defines more than 100 conditions that affect joints and other parts of the body. Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis, affecting more than 20 million people in the United States, who mostly are older than age 45 years.1 Osteoarthritis is caused by the progressive breakdown and eventual loss in the joints of cartilage that acts as a cushion between the bones. Most individuals show the effects in the hands, feet, spine, and large weight-bearing joints, such as the hips and knees.2 No specific treatment exists to halt the progressive degeneration of cartilage that osteoarthritis causes or to repair the damaged cartilage.3 Current treatments aim to reduce joint pain and inflammation, while improving and maintaining joint function.4 Acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are common treatments for patients with osteoarthritis.5 Although those therapies have known therapeutic value, they have also shown significant negative effect on human health.6 The issues include kidney damage and gastrointestinal side effects ranging from upset stomach, cramps, and diarrhea to ulcers and internal bleeding.6–8 The side effects have proven fatal in some cases.9 Alternatives to pharmaceuticals include natural therapies and nutritional supplements, such as glucosamine and chondroitin.10 Clegg et al11 found that both of those supplements were safe, with positive effects in patients with joint problems associated with osteoarthritis. However, that study’s findings were preliminary and not substantiated by results for its full cohort, providing mixed results at best. For many years, clinicians and researchers alike have sought to uncover or develop either natural or synthetic therapies that can achieve cartilage tissue repair, while they bypass the negative effects of cyclooxygenase 2 (COX-2) inhibitors and other NSAIDs. Bone morphogenetic proteins (BMPs) have been extensively investigated for the last 4 decades. They are now being targeted by leading biomedical and biotechnology companies as therapeutic agents that can reduce the cartilage damage that is associated with arthritis as well as contribute to regenerative medicine.12,13 In addition, recent studies have shown that BMPs were more effective when used in combination with growth factors, such as insulin-like growth factor (IGF).14 IGF is one of the key growth factors present in the currently investigated ingredient, Cyplexinol®, which is a protein complex that contains a combination of growth factors and BMPs that have been implicated in enhanced bone and joint health. Accordingly, the aim of the current study is to evaluate the clinical response to the ingredient to provide indications as to which pathways should be the focus of future research.