Prominent stem cell researcher disciplined.
Gabriel P Lasala, M.D. has signed a consent order under which he hasagreed to (a) serve five years of probation, (b) pay a $5,000 fine,(c) divest any interest he has in stem cell laboratories and relatedfacilities, (d) neither promote nor profit from any stem celltreatment that is not FDA-approved, (e) attend an approved seminar inprofessionalism and medical ethics, and (f) permanently refrain fromlecturing about stem cell treatments or representing that he is aresearcher or expert in the field of stem cell treatments.http://www.casewatch.org/board/med/lasala/order_2012.pdf Lasala, whopractices interventional cardiology in Covington, Louisiana, ispresident and a partner of TCA Therapy LLC, medical director of TCMTherapeutics, a partner in TCA Research, Inc, and a director of theStem Cell Foundation (a small private foundation).
TCA Cellular Therapy, LLC, a privately-held biotherapeutics company,has been conducting FDA-approved studies of stem-cell use againstheart disease, peripheral vascular disease, peripheral arterialdisease, limb ischemia, amyotrophic lateral sclerosis (Lou Gehrig'sdisease), and spinal cord injuries. In a 2010 publication, Lasalaindicated that TCA was looking for more investors and predicted thatLouisiana's Northshore would become "The Stem Cell Center," wherepeople from all over the world would come to receive therapy.[Northshore poised to become healthcare tourist Mecca. NorthshoreConifer, February 2010]http://www.tcacellulartherapy.com/pdf/NSC_FEB10_HEALTHCARE.pdf
The Louisiana State Board of Medical Examiners acted after it learnedthat Lasala was administering experimental therapies to patientsoutside of the trials and/or who did not meet the trial parameters.In 2011, the FDA warned him and TCA about multiple researchviolations that included (a) failing to test specimens from donorsfor communicable disease and (b) treating patients outside of thetrial protocols.http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm268796.htmSubsequent investigation by the Louisiana Board confirmed the FDAcharges and concluded that Lasala's Web site was making impropertherapeutic claims.