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The University of Rochester Medical Center has opened a facility that will enable researchers to create, study and use stem cells and their offspring in early-phase experimental human therapies, officials announced Wednesday.
The Upstate Stem Cell cGMP Facility, housed in UR’s DelMonte Neuromedicine Research Institute, will be used by academic and private-sector scientists in New York. It was created with a $3.5 million grant from the Empire State Stem Cell Board.
Several pending projects will immediately begin using the facility, including in the areas of macular degeneration, spinal cord damage, multiple sclerosis and bone transplants.
“One of the critical barriers to moving cell-based therapies into clinical trials is the requirement that these cells be manufactured in a facility that meets strict federal requirements,” said Steve Dewhurst, chair of the URMC Department of Microbiology and Immunology and principal investigator for the state grant. “Without this resource, much of this science remains stuck in the lab.”
The name cGMP— short for current good manufacturing practice—means the facility meets federal manufacturing guidelines necessary to ensure that biological materials produced there are suitable for human clinical trials.
These guidelines require that the lab is a clean room facility with strict air quality standards and is designed, maintained, and monitored in a manner that prevents contamination.
The new 3,600-square-foot facility consists of three separate labs and features redundant air handling systems, walls covered with a Fiberglas gel coat that aids in cleaning, and a building monitoring system that enables staff to remotely monitor air quality and room and equipment parameters 24 hours a day.
“Our scientists have made tremendous progress over the last several years unlocking the potential of stem cells to treat a long list of diseases,” said URMC CEO Bradford Berk, who also is a member of the Empire State Stem Cell Board. “I anticipate that this new facility will accelerate research across that state and make Rochester a center for the development of new cell-based therapies.”
There are more than 40 labs at URMC that are working with stem cells. These labs employ more than 260 scientists and technicians and collectively have more the $80 million in total research funding.
“This facility represents the key bridge to early stage trials in humans,” said Mark Noble, director of the URMC Stem Cell and Regenerative Medicine Institute. “We are now poised for early stage clinical studies in a wide range of conditions, including efforts to repair damage to the central nervous system, re-grow bone and cartilage, and even selectively target and destroy the stem cells that are the source of some forms of cancer.”
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