City of Hope receives contract to take stem cell research from 'bench to clinic'
Pasadena Star News, By Emma Gallegos, Staff Writer, January 21, 2010
Much is discussed these days about the need for
"Translational Research", meaning taking laboratory findings and "translating"
them into clinical approaches that may be implemented. Essentially, there is a
growing feeling that although significant sums of money have been invested into
understanding the molecular and cellular basis of many diseases, this
understanding has yet to yield drugs that actually help patients.
Today the City of Hope took a step closer to translating
basic research into treatments with the announcement of a $8.6 million contract
that was awarded by the National Heart, Lung and Blood Institute (NHLBI). The
contract is based on developing therapies using stem cell research, including
adult, embryonic, and inducible pluripotent stem cells. This contract will
enable the City to have the only designated stem cell production center in the
Dr. Larry Couture, the lead investigator for the awarded
contract stated "Embryonic stem cells just took a big giant leap into the
clinic." This comment however may be a little optimistic. The use of any cell
therapy approach in patients has to undergo FDA scrutiny, even if it is
originating from an academic institution. The issue with embryonic stem cells
appears not to be one of having production facilities, but addressing the FDA's
concerns, something with industry giant Geron is still in the process of.
That being said, numerous adult stem cell approaches have
entered the clinic and are yielding promising results for conditions ranging
from multiple sclerosis, to heart failure, to liver failure. Stem cells from
the fat, the bone marrow, and cord blood have all been used in clinical trials
in the USA. The establishment of the City of Hope stem cell processing facility
will allow for a centralized processing location which will be used by
scientists from across the United States. This will also allow for
standardization of protocols and development of uniform systems for evaluation
of processing methods as well as therapeutic safety and efficacy.
"Because the contract is the first of its kind, stem cell
researchers all over will turn to City of Hope as they approach the stage when
they need human clinical trials," Couture said. "What's cool for us is a large
of number of those technologies - regardless of where they come from in the
United States or around the world - will all come through our facilities,"
Numerous stem cell processing companies have existed in
private industry for years. One example is General Biotechnology Inc in
Indianapolis that processes fat, cord blood, and menstrual blood stem cells.
The advantage of the current approach is that it is an "open access" academic
hub that will support experimental efforts of scientists who do not have access
to the significant sums of capital needed to develop a cell processing facility
that meets FDA requirements.