NextCell Pharma has initiated patient enrolment for the high-dose group of the Phase IB clinical trial of ProTrans for the treatment of severe pneumonia.
Treatment with high-dose ProTrans has been proposed based on the review of the safety aspects of ProTrans by the Safety Committee in patients treated with a medium dose.
The committee evaluated data, including descriptions of adverse events.
Out of nine patients, a total of six have undergone treatment with low and medium doses of ProTrans so far.
The remaining three patients will now receive a high-dose using Wharton’s Jelly (WJ) Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans) to treat severe pneumonia caused by Covid-19, influenza, human metapneumovirus, and RS virus.
Early this year, a study of ProTrans was conducted to treat patients showcasing the same symptoms of severe pneumonia caused by SARS-CoV-2, as well as other viruses, including influenza A, respiratory syncytial, and human metapneumovirus.
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Approval for this study was received from the Swedish Medicines Agency. The study intends to save lives, as well as minimise hospital stays and rehabilitation times.
Treatment for Covid-19 with ProTrans has earlier been used in two clinical studies in Canada and Sweden.
NextCell is now focusing on testing the drug candidate ProTrans in development as an immunomodulatory cell therapy for treating type-1 diabetes. A Phase III study of ProTrans is currently underway for this treatment.
It is also planning to manufacture smaller quantities of ProTrans at its own GMP facility, which is expected to be completed this year.
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