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Stemming the pain of osteoarthritis
GERMANTOWN, Md.—South Korean biotechnology company RNL BIO has filed for U.S. Food and Drug Administration (FDA) approval to begin a Phase II clinical trial for its new product, RNL-JointStem, for the treatment of osteoarthritis.
RNL-JointStem is an adipose-derived adult stem cell product intended for the treatment of osteoarthritis. It is designed to be administered in a single injection of a stem cell product derived from the patient's own fat tissue to effectively regenerate cartilage, reduce pain and improve joint function in degenerative arthritis cases.
Phase I and Phase II clinical trials of RNL-JointStem have already been completed in South Korea under the authority of the Korean Food and Drug Administration (KFDA). Dr. Jason Dragoo of Stanford University and Dr. David Alan Fisher of Indiana University acted as reviewers and completed revisions of the protocol currently being evaluated by the FDA.
RNL BIO plans to conduct its double- blind, randomized, positive-control Phase II clinical trial during the third quarter of 2013 in Sugarland, Texas. The clinical trial will compare the efficacy of RNL-JointStem against existing therapies based on hyaluronic acid. The patient population for this trial will include osteoarthritis patients whose doctors nominate them for participation based on meeting candidacy requirements.
The intended market for RNL-JointStem is osteoarthritis patients under 60 years old, a patient group for which there is often no effective treatment and whose quality of life stands to improve greatly with effective management of the disease.
Osteoarthritis is the most common type of arthritis and the leading cause of chronic disability in the United States, according to the Centers for Disease Control and Prevention, afflicting nearly 27 million Americans. The prevalence of osteoarthritis, the aging population and the limits of current treatment methods indicate that the market for an effective and minimally invasive product for this indication would be enormous.
Osteoarthritis, also called degenerative arthritis, is a debilitating and progressive disease characterized by the degradation of the cartilage and bones of the joints. There is no cure for the disease. Cartilage has a limited capacity for healing and a poor ability to regenerate naturally. Current treatment courses usually begin conservatively with exercise, lifestyle change and pain relievers. As the disease progresses and the pain becomes debilitating, more drastic and invasive procedures including cortisone injections, osteotomy (bone realignment) and joint replacement may be considered.
Although the underlying causes of degenerative arthritis are not completely mapped, injuries, age and heredity are widely considered to be major contributing risk factors.
The key advantage RNL-JointStem has demonstrated in previous trials is its effectiveness as a single- injection treatment, which is vastly simpler than the enduring lifestyle changes used to manage the disease in its early stages, and far less invasive than the late-stage treatment options available today.
"We are hoping to confirm that RNL-Joint Stem is effective for cartilage regeneration, pain reduction and improved joint function in patients with osteoarthritis, and that it will eventually be accepted in the market." Dr. Jeong-Chan Ra, CEO and chairman of RNL BIO, said in a media release.
RNL BIO's application for RNL-JointStem is in the form of an Investigational New Drug (IND) application. Approval of an IND application is required to conduct a clinical trial in the United States. This application contains data from preclinical studies as well as information about how the product is intended for use clinically, plus an overall risk-benefit assessment. Studies of clinical treatments with biologic medical products, including stem-cell therapies, are closely regulated by the FDA's Center for Biologics Evaluation and Research.
RNL BIO is a biotechnology company focused on stem cells and the development of autologous cell therapies for various degenerative, ischemic and other indications. Its focus is on research and development of adult-derived stem cell technologies. The company has completed a Phase I trial for spinal cord injury and a Phase II clinical trial for osteoarthritis under the KFDA in South Korea, and it is nearing completion of a clinical trial for Buerger's Disease.