(majestic music) - hi, i'm roberto bolli fromthe university of louisville. i'm a speaker at the 2014 meeting of the basic cardiovascular sciences council. my talk is scheduled on thursday morning and it's entitled advancesand lessons learned from clinical trials with stem cells. the main point of mypresentation will be to discuss where we are withclinical investigation
of cell therapy and where we should go. there has been a lot ofconcern lately regarding the efficacy of cell therapy, and some have even gone asfar as questioning whether the clinical trials ofstem cells should continue. i think that it is veryimportant to rely on data and not on personal or subjective opinions of the individual investigators. so let's look at the data achieved so far.
stem cell therapy is a veryrecent field of investigation. for practical purposes clinical trials started roughly 10 years go. there have been numerous studies of different types of stem cells in patients with cardiovascular disease particularly in patients with acute myocardial infarctionand with heart failure. most of these studies havebeen relatively small studies.
phase i or phase ii trials witha limited number of subjects and that is expected in a newfield that is just starting. so just because trials have been small does not mean that the results are not meaningful or significant. this is the initial necessary phase of any field of clinical investigation. the best way to interpretthese small studies is by looking at meta-analysis of the
data that had been conducted so far. so instead of expressingopinions regarding a certain type of cell or whether a certaintype of study should go on we should look at the evidence and the best evidence we have are the results of meta-analysis of studies conducted heretofore. there was a recentmeta-analysis published in 2014 in the european heartjournal by the colleagues
that examined all clinicaltrials that were done in patients with myocardialinfarction or stem. so the total number of subjectsis actually quite large. more than 1,600 patients andreviewed a total of 16 studies and the conclusion of thismeta-analysis was that the aggregate there is asignificant improvement in left ventricular ejectionfracture of approximately 3% as well as a reduction in left ventricular and systolic wall.
this is a large number of subjects and certainly although thedata clearly not conclusive, this kind of data support continuing further investigations inthis patient population. it should be pointedout that there were also no significant adverseeffects in these trials that could be ascribed to cell therapy. perhaps even more promisingthan acute myocardial infarction is the setting of heart failure.
in my opinion that isthe clinical situation in which cells will probablythe greatest impact. so the most authoritativemeta-analysis in this area is published by thecochrane group in oxford. their latest paper waspublished online in april, 2014. they reviewed 23randomized clinical trials involvedign more than 1,200 patients with heart failure that weretreated with cell therapy. and the conclusion ofthis very careful analysis
is that there is moderate quality evidence that cell therapy does indeedimprove ejection fraction and uses systolic volumeas well as diastolic volume in this patient population. in addition they foundmoderate quality evidence that cell therapy improvesfunctional capacity. in new york heartassociation classification. so these are importantconclusions that again provide a more than adequatejustification in my mind
for pursuing studies of cell therapy in these patient populations. now with regard specificallyto cardiac stem cells the data are limited. there has been a study ofc-kit-positive cardiac stem cells. a c-kit trial which wasconducted in patients with ischemic heart failure andhas shown encouraging results and no adverse effectsascribable to cell therapy. there has been a study ofcardiosphere-derived cell therapy.
the caduceus trial inpatients with a recent acute myocardial infarction which suggests a reduction in infarc size and again no adverse effectsascribable to cell therapy. i think both of these studiesprovide adequate justification for pursuing the investigationof these cell types. i think that although wedon't have conclusive evidence at the moment cell therapy doespositively affect an outcome in patients with cardiovascular disease.
there is sufficient evidence to justify continuing investigationand more importantly moving to larger andmore conclusive trials, i.e. phase iii trials in these patients. indeed there are already several such phase iii trials going on and we are anxiously awaitingthe results of these studies. finally we must alwayskeep in mind that our first and foremost responsibilityis to our patients.
many heart disease patients, particularly patients with heart failure, have few options and a verygrim prognosis at present. now cell therapy offersthese patients a new hope and a new option which isnot currently available and we must try to makethis option available to this large patient population. so if the trials for celltherapy produce the results that we hope they willthis will definitely
and possibly dramaticallyimprove the outcome in a large number ofpatients with heart disease and certainly in thatsense cell therapy fits in the broader mission of theamerican heart association which is to build healthier lives, free of cardiovascular disease and stroke.
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