Recent clinical trial failures in cardiac stem cell therapies have been widely reported as raising more questions than answers in a field which already had many unknowns. But those questions themselves give rise to new strategies spurring the formation of start-ups like those profiled in this issue. While the new companies are ultimately addressing heart failure, they hope to intervene much earlier in the cascade of damage and remodeling, where turning up the body's natural healing responses a notch could help it repair the damage caused by myocardial infarction or ischemia. Many cardiac cell and gene therapy companies are returning to ischemic disease, a field in which, in recent years, the success of device-based revascularization techniques appeared to present a competitive hurdle to cell and gene therapies. Microvessel disease is emerging as a large market in which cell and gene therapies might have advantages over devices.
In basic research, all knowledge is good; even failed
experiments are useful because they help shape future hypotheses
and experiments. By the unflappable way that the clinical
community, industry and the government funding agencies continue to
fund and support cardiac regeneration, despite a string of clinical
failures, one might judge that cardiac gene and cell therapy
efforts to have barely moved beyond the basic research phase.
For years, the clinical challenges and economic consequences of heart failure have made it a disease that merits investing in...
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The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.
With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.
The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.
