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Regenerative medicine could potentially displace standard of care treatments used for chronic diseases such as heart failure or diabetes within the next decade, according to data and analytics company GlobalData. Currently, small bio-techs are leading R&D efforts on a variety of cardiovascular (CV) stem cell therapies, while big pharma drives metabolic disorder (MD) stem cell therapy research, with AstraZeneca, Johnson & Johnson, Novo Nordisk and Sanofi gearing up to develop novel treatments for diabetes. Within the entire cardiovascular and metabolic disorder (CVMD) space, the current stem cell pipeline features approximately 116 candidates. However, the majority (54%) of the pipeline candidates are in preclinical development, with only 6% of candidates being evaluated in Phase III clinical trials.
Of all the CVMD stem cell pipeline therapies, 73% target CV indications and 27% target metabolic indications. Within the CV stem cell therapies, a disproportionately large number of them target heart disease indications, such as heart failure, cardiomyopathy, left ventricular dysfunction and myocardial infarction.
Regenerative therapies targeting cardiovascular indications aim to demonstrate that stem cells introduced into the body can induce the formation of new capillaries or/and improve function of impaired or injured heart tissue. Prominent mid- to late-stage CV stem cell pipeline candidates such as Mesoblast’s Revascor, Celixir’s Heartcel, and Capricor’s CAP-1002, target heart failure, a chronic disease with a slew of unmet needs. Key opinion leaders (KOLs) interviewed by GlobalData indicated that they are eager to have these novel treatments at their disposal, especially for patients with advanced heart failure and unable to receive a heart transplant, patients with non-ischemic cardiomyopathy, and heart failure patients with preserved ejection fraction. GlobalData analyst Jesus Cuaron, Ph.D., P.P.M., commented: “Despite big pharma investment in MD stem cell therapies, the majority of the candidates are still in early R&D stages, whereas several CV stem cell therapies are already in Phase II or Phase III clinical trials. It is therefore highly probable that marketed “off-the-shelf” CV stem cell therapies will become available within the next decade.”