Boston University (BU; Boston, Massachusetts) has struck a deal that would allow a new company to sell analyses of data from the university's Framingham Heart Study, pioneering research into heart attacks and strokes that has been going on for more than half a century. The study has amassed a huge collection of genetic, clinical and behavioral data from the 10,000 participants, all families from the western Boston suburb.

The university will own 20% of the new company, Framingham Genomic Medicine Inc. Venture capitalists have committed $21 million to form the company. Pharmaceutical and biotechnology companies are expected to pay annual fees to access the medical information, which will be placed in a huge electronic database, the Boston Globe reported.

University spokesman David Lampe said the company would sell analyses of the data, not the data itself, which is already free to researchers. "All the data is available to everyone for free. It always has been. It always will be," Lampe said. "We are not selling any Heart Study data for a profit, only the analyses."

The university said patient privacy would be protected. Only two of the study's 6,000 surviving participants have asked that their records be excluded.

Dr. Fred Ledley, Framingham Genomic Medicine's chief scientific officer, said the forthcoming release of the first draft of the human genome – the mapping of more than 100,000 genes – means the database will be a resource for pharmaceutical researchers looking to identify the connection between specific genes, and health and disease outcomes.

Ledley said stock in the company would be put in a charitable trust for the benefit of the city of Framingham. Lampe said the company also would help fund an ethics advisory board and science education in the city's schools.

Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute (Bethesda, Maryland), which has contributed more than $40 million to the heart study, expressed reservations about the proposal, saying he didn't want one company to have exclusive access to the data. "This data was obtained with public money. Why should we give access to one person or one company?" he asked.

He said agency lawyers were reviewing the institute's agreement with BU, and is still sorting out who owns which portion of the heart study data.

The Framingham Heart Study has been collecting data for 52 years, accumulating vast amounts of information, including 500,000 chest X-rays and electrocardiograms, 5,000 blood samples and truckloads of paper medical records that include diet diaries and even early studies of male balding patterns.

More than 1,000 published studies have stemmed from the data collected from Framingham residents on their lifestyle and health patterns.

ATS, others try to grow heart tissue

In the hopes of facilitating the development of tissue-engineered hearts, the National Institutes of Health (Bethesda, Maryland) is funding a $10 million effort to grow patches of cardiac muscle in the laboratory setting.

The five-year research project is being headed by bioengineering researchers at the University of Washington (Seattle, Washington) and includes Advanced Tissue Sciences (ATS; San Diego, California), as well as researchers from the Hope Heart Institute (also Seattle), the University of Toronto (Toronto, Ontario, Canada) and Advanced Polymer Systems (Redwood City, California).

"We are pretty excited about this grant," said Jana Stoudemire, senior director of corporate communications for ATS. "We're very happy to be part of this grant as a collaborator. It really recognizes the tremendous potential for tissue engineering."

The grant really represents the first step in a two-stage process. The grant will be used primarily to grow thick patches of cardiac muscle under the direction of University of Washington bioengineering professor Buddy Ratner, who is serving as principal investigator for the project. Those muscle patches could be grafted onto weakened hearts in order to improve their efficiency.

Then, once the researchers develop these cardiac tissue patches, they will apply for another five-year grant to develop a "ventricular tube" and a full ventricle. The ventricular tube is a cylinder of rolled cardiac muscle with valves that could assist a weakened heart with pumping. The goal is to enable scientists to grow a fully functioning human heart.

ATS specializes in growing cells into 3-dimensional products on a scaffold. The company will be using its expertise and patented technology to enable the cardiac tissue-engineering project. Using its technology, ATS has developed Dermagraft – a living, metabolically active skin implant derived from fibroblasts from discarded human foreskin tissue. Dermagraft is being developed for the treatment of foot ulcers.

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