Tuesday, November 15, 2005

1-866-GRO-BONE

by Zoe Philip (Class of '05)

The Stryker Biotech division of Stryker Corporation has made a giant step forward in the regeneration of human tissue. Their studies are focused on the renewal of various human tissues that have been damaged through disease or injury. Currently, their lead drug on the market is a protein called Bone Morphogenic Protein 7 (BMP7). It is approved in thirty different countries including the European Union, the United States, Australia, Canada, and Switzerland. The presence of BMP growth factors, a molecule capable of stimulating the renewal of cells, was first hypothesized in the mid sixties by an orthopedic surgeon, Doctor Marshall Urist. By the seventies BMP7 had been discovered, and Stryker acquired the rights to study and manufacture the protein by the early nineties.

BMP7 is capable of stimulating the regeneration of bone. The protein can stimulate fractures to heal and can create bone fusions, in areas such as the spine. All it takes is a local injection (injection at the site of injury) of the protein. The protein then reacts with receptors on mesenchymal stem cells. These stem cells are present in adults as cells designated to manufacture more of a mesenchymal tissue, such as bone. The purpose of the protein is to attach to the ACTII receptors, which stimulate the Smad pathway. The Smad pathway is the pathway within the bone cells whose job it is to tell it to make more cells. In some people, fractures just will not heal because their stem cells are not being stimulated to produce more tissue. When BMP7 is injected into a person, it provides them with the necessary protein to trigger regeneration. BMP7 is just the first step towards discovering and manipulating others proteins that can regenerate other tissues besides bone.

Three components are needed to regenerate tissues: stem cells, a signal to stimulate the stem cells, and a matrix, a substance onto or into which the new cells can grow. The stem cells are already present in most tissues from birth. In the case of re-growing or creating bone, the signal for the cell to begin producing more tissue is the BMP7 protein. In order for the injection of BMP7 to work Stryker Biotech has created several different matrices. One of them is called Bovine Collagen and is used for healing fractured bones. Another, Tricalcium Phosphate, is used in spine fusions. Through the production of these materials, Stryker has made it possible for tissues to heal.

In recent pre-clinical trials, BMP7 has shown that it is capable of regenerating cartilage. If the studies show that the protein is capable of consistently producing new cartilage, then it could be used to cure Degenerative Disk Disease and Ostero-Arthritis, and heal sports injuries. Unfortunately the process of getting a drug to the market is time-consuming and expensive. A new drug must be proven to be safe, effective, and able to be manufactured consistently. On average it takes about 15 years and about 800 million dollars to bring a drug to market. Despite the time and the cost though, the efforts are worth it, bringing relief to patients in pain.

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