Very important key words from linked page, "May" and "Study suggests" and :
"Grines said she looks forward to reviewing safety data from the new trial and future trials, since needle injections can cause an increased incidence of irregular heart rhythm. The tiny scars left by the needle can divert the electrical signals of the heart."
That's a BIG ONE IMHO- messing with heart rhythm, up to and including, potential death of the patient cited in several studies/reports. Where has that been heard before? This is far from being settled science or even close to slam-dunk technology IMO from all the various sources/reports. Seems it's years, many years out from any FDA or Euro type approval IMO.
BHRT, latest 10-K, PAGE 31:
"Possible side effects of our product candidates may be serious and life-threatening. A number of participants in our clinical trials of MyoCell have experienced SERIOUS adverse events potentially attributable to MyoCell, including six patient DEATHS and 18 patients experiencing irregular heartbeats. A serious adverse event is generally an event that results in significant medical consequences, such as hospitalization, disability or death, and must be reported to the FDA. The occurrence of any unacceptable serious adverse events during or after preclinical and clinical testing of our product candidates could temporarily delay or negate the possibility of regulatory approval of our product candidates and adversely affect our business."
" Both our trials and independent trials have reported the occurrence of irregular heartbeats in treated patients, a SIGNIFICANT RISK to patient safety. We and our competitors have also, at times, suspended trials studying the effects of myoblasts, at least temporarily, to assess the risk of irregular heartbeats, and it has been reported that one of our competitors studying the effect of myoblast implantation prematurely discontinued a study because of the high incidence of irregular heartbeats. While we believe irregular heartbeats may be manageable with the use of certain prophylactic measures including an ICD, and antiarrhythmic drug therapy, these risk management techniques MAY NOT prove to sufficiently reduce the risk of unacceptable side effects."
Seems like a common, potential problem IMO, maybe a big one? A competitor, it says, prematurely discontinued a study they felt the issue serious enough. Interesting to say the least.
