FLORIDA - BACKGROUND: Buerger’s disease, thromboangiitis obliterans, is a rare disease of the arteries and veins in the arms and legs. The blood vessels become inflamed, swell, and can become blocked with blood clots (thrombi). Eventually skin tissues will get destroyed and may lead to gangrene and infection. As Buerger’s disease develops, it will show in the feet and hands first. It can eventually affect larger areas of the legs and arms. Buerger’s disease is rare in the United States, but is more common in the Middle and far East. It usually affects men who are younger than 40. However, it is becoming more common in women. Almost everyone who is diagnosed with Buerger’s disease smokes cigarettes or used other forms of tobacco. (Source: www.mayoclinic.com)
TREATMENT: Treatment can not cure Buerger’s disease. Doctors say the most effective way to stop the disease’s progress is to quit using tobacco products. Doctors can recommend non-nicotine medications that can be used to help the patient stop smoking and stop the swelling. Another option is a residential smoking cessation program, which is similar to a rehabilitation program. Other treatment options exist, but are less effective. (Source: www.mayoclinic.com)
NEW TECHNOLOGY: Biomet, Inc., a global manufacturer of orthopedic and biotechnology products, and its subsidiary, Biomet Biologics, sponsored the Phase I clinical trial of MarrowStim™ investigational device for individuals with critical limb ischemia. Critical limb ischemia (CLI) is a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral artery disease (PAD). MarrowStim™ utilizes the body’s own concentrated bone marrow to possibly improve blood flow in legs with blocked arteries by attempting to create new blood vessels. The procedure involves removing bone marrow from the hip bone and transferring it to the investigational device for processing and concentration. Once it is processed, the marrow is injected into the affected limb. The marrow contains mononuclear cells that may have the potential to treat diseased vascular structures. Doctors believe this treatment could help many people with circulation problems, like Buerger’s disease and PAD.
The trial was performed under an FDA-approved Investigational New Drug (IND) Application to evaluate the safety of autologous concentrated BMA therapy in 29 “no option” CLI subjects who were at risk for major amputation due to severe PAD. The results included: no reports of procedure-related deaths; two reports of procedure-free survival rate of 86.3%; improvement in rest pain, quality of life, and perfusion measures at 12 weeks after treatment; and overall average procedure time of less than two hours. Biomet Biologics advanced the MarrowStim™ technology into a multicenter trial under an FDA-approved Investigational Device Exemption (IDE). The trial will enroll a total of 152 patients and is currently ongoing at 14 investigational sites. Study participants will be randomized to either receive MarrowStim™ treatment or placebo, 75% will get MarrowStim™ and 25% of patients will receive placebo. Enrollment began in June 2010 and is estimated to end in May 2013, with completion of one-year data collection in May 2014. (Source: www.reuters.com) For enrollment information go to: http://clinicaltrials.gov/ct2/show/NCT01049919?term=biomet+pad&rank=1 or call: (877) 788-3972