I wonder why they require treatment within 14 days of injury and why only paras in the trial?
At 11:43 AM 10/12/2010, Derrick wrote: > >Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy in >Patients with Spinal Cord Injury > > > >October 11, 2010 7:30 AM ET > >Geron Corporation ><http://news.moneycentral.msn.com/inc/news/quoteredir.asp?symbol=US:GERN>GERN >today announced the enrollment of the first patient in the companys clinical >trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor >cells, GRNOPC1. The primary objective of this Phase I study is to assess the >safety and tolerability of GRNOPC1 in patients with complete American Spinal >Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord >injuries. Participants in the study must be newly injured and receive GRNOPC1 >within 14 days of the injury. > >The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain >injury rehabilitation hospital and clinical research center in Atlanta, GA. >Shepherd Center is one of seven potential sites in the United States that may >enroll patients in the clinical trial. > >Initiating the GRNOPC1 clinical trial is a milestone for the field of human >embryonic stem cell-based therapies, said Thomas B. Okarma, Ph.D., M.D., >Gerons president and CEO. When we started working with hESCs in 1999, many >predicted that it would be a number of decades before a cell therapy would be >approved for human clinical trials. This accomplishment results from extensive >research and development and a succession of inventive steps to enable >production of cGMP master cell banks, scalable manufacture of differentiated >cell product, and preclinical studies in vitro and in animal models of spinal >cord injury, leading to concurrence by the FDA to initiate the clinical >trial. > >We are pleased to have our patients participating in this exciting research, >said Donald Peck Leslie, M.D., medical director, Shepherd Center. Our medical >staff will evaluate the patients progress as part of this study. We look >forward to participating in clinical trials that may help people with spinal >cord injury. > >David Apple, M.D., Shepherd Centers medical director emeritus and principal >investigator of the trial at Shepherd Center, said, This clinical trial >represents another step forward in Shepherd Centers involvement in an attempt >to find a cure for paralysis in people with spinal cord injury. Shepherd >Center is an ideal place to conduct this study because of our clinical >expertise and the volume of patients referred here for rehabilitation care. > >In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also >open for patient enrollment. As additional trial sites come online and are >ready to enroll patients, they will be listed on the Patient Information pages >of Gerons website at ><http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.geron.com%2Fpatients%2Fclinicaltrials%2FhESC.aspx&esheet=6461768&lan=en-US&anchor=www.geron.com%2Fpatients%2Fclinicaltrials%2FhESC.aspx&index=1&md5=3837ac1427363caca9d02514e50d900b>www.geron.com/patients/clinicaltrials/hESC.aspx > and on the NIH clinical trials registry, ClinicalTrials.gov, at ><http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT01217008%3Fterm%3DGRNOPC1%26rank%3D1&esheet=6461768&lan=en-US&anchor=clinicaltrials.gov%2Fct2%2Fshow%2FNCT01217008%3Fterm%3DGRNOPC1%26rank%3D1&index=2&md5=05e3b7b97783728420c58b39df62f7f9>clinicaltrials.gov/ct2/show/NCT01217008?term=GRNOPC1&rank=1. > > >Further information on the criteria for patient eligibility for the study is >also available on ClinicalTrials.gov. > >About Spinal Cord Injury > >Spinal Cord Injury (SCI) is caused by trauma to the spinal cord that results >in a loss of such functions as locomotion, sensation or bowel/bladder control. >A traumatic blow to the spine can fracture or dislocate vertebrae that may >cause bone fragments or disc material to injure the nerve fibers and damage >the glial cells that insulate the nerve fibers in the spinal cord. Most human >SCIs are contusions (bruises) to the cord, rather than a severance of the >nerve fibers. Every year approximately 12,000 people in the U.S. sustain >spinal cord injuries. The most common causes are automobile accidents, falls, >gunshot wounds and sports injuries. > >About GRNOPC1 > >GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have >demonstrated remyelinating and nerve growth stimulating properties leading to >restoration of function in animal models of acute spinal cord injury. >Preclinical studies showed that administration of GRNOPC1 significantly >improved locomotor activity and kinematic scores of animals with spinal cord >injuries when injected seven days after the injury. Histological examination >of the injured spinal cords treated with GRNOPC1 showed improved axon survival >and extensive remyelination surrounding the rat axons. For more information >about GRNOPC1, visit ><http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.geron.com%2FGRNOPC1Trial%2F&esheet=6461768&lan=en-US&anchor=www.geron.com%2FGRNOPC1Trial%2F&index=3&md5=691356f91856e5fdbb03602eae46360d>www.geron.com/GRNOPC1Trial/. > > >About Shepherd Center > >Shepherd Center is a private, not-for-profit rehabilitation hospital >specializing in medical treatment, research and rehabilitation for people with >spinal cord injury and disease, brain injury, multiple sclerosis, chronic pain >and other neuromuscular conditions. Each year Shepherd Center admits more than >940 inpatients and more than 530 day program patients. Its staff also treats >about 6,000 people on an outpatient basis annually. For more information, >visit Shepherd Center online at shepherd.org. > >About Geron > >Geron is developing first-in-class biopharmaceuticals for the treatment of >cancer and chronic degenerative diseases, including spinal cord injury, heart >failure and diabetes. The company is advancing an anti-cancer drug and a >cancer vaccine that target the enzyme telomerase through multiple clinical >trials. For more information, visit ><http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.geron.com&esheet=6461768&lan=en-US&anchor=www.geron.com&index=4&md5=58ba2528c97da8704c46a1453cd2693a>www.geron.com. > > >This news release may contain forward-looking statements made pursuant to the >safe harbor provisions of the Private Securities Litigation Reform Act of >1995. Investors are cautioned that statements in this press release regarding >potential applications of Gerons human embryonic stem cell technology >constitute forward-looking statements that involve risks and uncertainties, >including, without limitation, risks inherent in the development and >commercialization of potential products, uncertainty of clinical trial results >or regulatory approvals or clearances, need for future capital, dependence >upon collaborators and protection of our intellectual property rights. Actual >results may differ materially from the results anticipated in these >forward-looking statements. Additional information on potential factors that >could affect our results and other risks and uncertainties are detailed from >time to time in Gerons periodic reports, including the quarterly report on >Form 10-Q ! for th e quarter ended June 30, 2010. > >[] > > >Geron: >Anna Krassowska, Ph.D., 650-473-7765 >Investor and Media Relations ><mailto:[email protected]>[email protected] >or >Shepherd Center: >Jane Sanders, 404-350-7707 >Public Relations ><mailto:[email protected]>[email protected] > >Copyright 2010 Business Wire >
