CardioCell offers bright spot in stem cell development
- CardioCell reported positive Phase II data for its intravenous stem cell therapy for the treatment of chronic heart failure at the European Society of Cardiology meeting in Rome on Sunday.
- The study represented the first positive trial of IV ischemia-tolerant mesenchymal stem cells (itMSCs) in patients with chronic heart failure, after several other companies have failed in the space.
- The data showed statistically significant improvement in 6-minute walk test, KCCQ Clinical Summary score and trend to improvement in KCCQ Functional Status score.
After several failures in the heart failure space for stem cells, Stemedica subsidiary CardioCell announced positive data on August 28 showing its stem cells just might have potential in this indication.
Other therapies have tried to administer large amounts of stem cells directly to the heart via catheter or surgery, but those efforts have always failed. The CardioCell trial showed IV administration might be the best route. Yet, the company will still have to pass the Phase 3 hurdle.
The single site study included 22 patients that were randomized to either itMSCs or placebo, both delivered via IV. Patients were checked at baseline, 90 days and 180 days.
"Based on these promising clinical-trial findings, CardioCell is excited to be developing larger studies based on IV delivery of our itMSCs for heart failure indications, including both non-ischemic and ischemic cardiomyopathy," said Sergey Sikora, CEO of CardioCell and co-author of the study, in a statement.
Celyad, another developer in the space, announced in June its stem cell therapy flopped in Phase 3. The biotech tried to salvage the news and pointed to positive trends in a subgroup population.
Other stem cell companies have also hit setbacks—Teva pulled out of a stem cell deal with Mesoblast and BioCardia withdrew its IPO in recent months.
- CardioCell Statement
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