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What are BMPs ?

Bones are made up of about 65-70 percent mineral and 30-35 percent organic matrix.

Bone fractures and other bone disorders are very common in everyday life.  In the U.S. alone, Americans suffer roughly 5 million bone fractures and surgeons perform 3 million orthopedic operations every year, according to the American Academy of Orthopedic Surgeons.

For even a simple minor fracture, a few weeks in a cast are needed for the bone to heal itself.   For more severe fractures, the healing process often requires surgical operations and long periods of bed rest and rehabilitation.   This imposes great physical and financial pain on the patients, their families and society in general.   Furthermore, in many clinical cases, the ununion bone defects are difficult to repair and often require painful bone grafts.  The patients suffering from this kind of bone fracture or disorders will be deprived of a normal lifestyle.

Therefore, it is highly desirable to develop a therapeutic drug that could enhance bone growth and bone healing so that the normal union bone healing period could be shortened, ununion fracture or defects could be healed and the bone graft implant required in spinal fusion, ununion fracture and plastic surgery could be replaced.

The process of stimulating bone growth within the body is known as osteoinduction.

In 1965, Dr. Marshall Urist of the University of California at Los Angeles (UCLA) discovered that he could promote new bone formation by demineralizing the bone and placing only the organic matrix part into the muscle of rats.   This discovery led to more than three decades of extended research which proved that a series of proteins found in the bone matrix, collectively known as Bone Morphogenetic Proteins (BMPs), are responsible for the bone formation observed by Dr. Urist.   Such BMPs are found only in traces in the human body.   However, scientists have demonstrated that genetically produced BMPs such as BMP-2 have the ability to stimulate a patient's own cells to make more bone.

In 1977, recombinant BMP-2 was used for the first time in patients undergoing spinal fusion.   The  United States Food and Drug Administration (FDA) announced in July last year the approval of a medical device which uses recombinant human BMP-2 to stimulate bone growth in spinal fusion operations.   The FDA's Orthopedic and Rehabilitation Devices Advisory Panel also voted 6-to-1 in late November last year to recommend approval of recombinant human BMP-2 applied to a collagen sponge for the treatment of open long-bone fractures.

FDA Links

www.fda.gov/bbs/topics/answers/2002/ans01155.html

www.fda.gov/ohrms/dockets/ac/02/transcripts/3910t2.pdf

(Last updated on October 21, 2003)