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Doris A Taylor
American Heart Hospital Journal Volume 9 No.1

Predicting the future of any innovative treatment is always risky and yet most of the predictions that were made in 2006 with regards to cell therapy have come to fruition. Let us look at where we were and where we are now. In 2006, we had moved from the idea of cell therapy through a number of preclinical models into early clinical applications, using a number of cell types, yet we were iterating between clinical application and unanswered basic questions. There were a huge number of unmet clinical needs and straightforward questions that had not been answered. Some of the general questions at the time were:

• 'what cell should we choose for what patient?';
• 'what is the proper route of administration?'; and
• 'how should we determine if cell therapy was efficacious (what endpoints should we use)?' The more specialized questions were:
• 'how can we improve cell delivery, retention, and tracking?';
• 'are any cells unsafe?';
• 'what is the mechanism of cell action?';
• 'are there better cells?'; and
• 'do we need cells at all?'

In 2006, I predicted we would see surgical and percutaneous phase I studies with bone marrow, blood, and adipose-derived cells completed, and that we would likely see initiation of at least one trial with cardiac-derived cells. I also predicted that cell types would segregate with disease state, and that this would likely include the use of bone marrow-derived cells in the acute and subacute setting of myocardial infarction, and myoblasts or bone marrow or fat-derived mesenchymal cells in patients with heart failure (HF). How did I do?

As of May 2011, over 416 studies have been registered with www.clinicaltrials.gov under the terms 'stem cells' and 'heart', and at present, 144 of these studies are actively recruiting, which means over 250 studies have been completed or have stopped enrolling. According to a review of the field in 2009,¹ 95 studies were registered worldwide; 40 of them in Europe. The majority of the studies were phase II studies with 14 % having progressed to phase III and 1 % at phase IV. Almost half of the studies were on patients with acute coronary syndrome, around 30 % on patients with HF, and about a quarter on patients with chronic heart disease. The vast majority of cells being evaluated are blood- or bone marrow-derived cells (96 %) with myoblasts- and adipose-derived cells comprising the remainder. In 2011, at least two cardiac stem cell trials have begun in the US,^2,3 and it is anticipated that others will emerge in the short term. At www.ncbi.nlm.nih.gov/pubmed over 6,400 manuscripts have been published with the keywords 'stem cells' and 'heart'. More publications are emerging every day.

View Article Here

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• Doris A Taylor, PhD, FAHA, Director, Center for Cardiovascular Repair, University of Minnesota
• Correspondence: Doris A Taylor, PhD, FAHA, Department of Integrative Biology and Physiology and of Medicine, Center for Cardiovascular Repair, 312 Church Street SE, 7-105A NHH, Minneapolis, MN 55455. E: ccvr@umn.edu