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Histocell starts a clinical trial with its cell therapy drug HC016 in patients with ARDS due to COVID-19


The most serious complication of COVID-19 infection is Acute Respiratory Distress Syndrome (ARDS). More than 40% of seriously hospitalised patients develop ARDS, and about 50% with moderate-severe ARDS die because of it. Taking into account the proven safety and efficacy of mesenchymal cells in diseases that occur with a process of exacerbated inflammation, several groups, including the one led by Dr. Dongcheng Wu in Wuhan (China), have focused their efforts on cell treatment for critically ill COVID-19 patients with promising results.

Histocell has spent the last years developing a cell therapy drug for ARDS, HC016, based on adult stem cells obtained from adipose tissue, designed to survive in highly inflammatory environments, and subsequently, with greater therapeutic potential than traditional mesenchymal cells. Thus, HC016 cells are especially suitable for the treatment of ARDS that occurs in COVID-19 patients. Histocell has already demonstrated preclinical efficacy of HC016 cells in ARDS indication, as well as their safety and potential clinical efficacy in patients with acute spinal cord injury. HC016 cell therapy drug is ready for patient application and can be stored cryopreserved in the hospital.

Histocell has currently a Phase I/II clinical trial approved by the Spanish Drug Agency for intravenous administration of HC016 in patients with ARDS. This clinical trial will be carried out in collaboration with Biocruces-Instensive Medicine Service of the Cruces Hospital. Patients with respiratory distress derived from COVID-19 meet the criteria to participate in this clinical trial, whose objectives are to help the patient overcome the ARDS situation, decrease the mortality rate and damage caused to the lung tissue in the medium-long term.

In May 2020, this clinical trial will begin in 26 patients with ARDS caused by COVID-19, at the Cruces Hospital (Bizkaia, Spain). The aim is to reduce pulmonary inflammation and overcome the ARDS situation, avoid the establishment or irreversible damage to the lung tissue and, therefore, improve the patient’s clinical situation.

More information about HC016 Acute Lung Injury

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