Histocell successfully completes the clinical safety phase of its cell therapy drug HC016 for the treatment of acute respiratory distress caused by COVID-19


This is the Phase I clinical trial of the cell therapy drug HC016 developed by Histocell, which is being carried out at the Hospital de Cruces (Bilbao), in Spain. The objective of this trial is to offer a treatment to help overcome Acute Respiratory Distress Syndrome, the most serious complication caused by COVID-19 and the main cause of death from the disease. Histocell is among the group of companies that is working on cell therapies worldwide for this disease, with a patented and unique technology.

Histocell has successfully completed phase I of the clinical trial of the cell therapy drug HC016, which has been developed to treat Acute Respiratory Distress caused by COVID-19 , the leading cause of mortality of the disease. The external safety committee has confirmed the safety of the drug in the treatment of patients, which has been carried out without adverse effects associated to it. In addition, the results have shown signs of efficacy, so the team hopes to confirm it in phase II, which has already started.

“In May we announced the start of the clinical trial with great enthusiasm and after 7 months of work, we can say we have finished phase I with great hope”.

Julio Font,CEO of Histocell


Acute Respiratory Distress Syndrome (ARDS) is the most serious complication caused by COVID-19. More than 40% of seriously ill hospitalised patients develop it, and around 50% with moderate-severe ARDS die from it. The objective of this medication is to help patients overcome this complication, reduce the mortality rate and minimise the damage caused to the lung tissue in the medium-long term. The results of the phase I go one step further in achieving these objectives.

The trial, which has been partially funded by the Basque Government within the framework of the COVID-19 R&D grants, is being carried out in the Intensive Care Unit of the Cruces Hospital, managed by the Biocruces Health Research Institute, in Bilbao. The principal researcher, Dr. Fermín Labayen, Chief of Intensive Medicine, leads the trial together with the main clinical team that includes Dr. Pablo Serna, Dr. Tomás Muñoz and Dr. Victoria Boado, in addition to the rest of the ICU team.

The HC016 cell therapy drug is indicated for patients in critical condition. For Julio Font, the news of the completion of this first phase has positive readings in many ways. We are facing an important milestone, because in this case we are treating patients who enter the ICU. For the society, it gives us hope to minimise the mortality and complications of COVID-19. An in our sector, it places us at the global forefront.

Histocell has been developing this cell therapy drug for Acute Respiratory Distress for more than 7 years. In December 2019, the Spanish Agency for Medicines and Health Products (AEMPS) authorised phases I and II of the clinical trial, which started in May 2020, in collaboration with Biocruces.

Patented cell therapy

Histocell, specialised in advanced therapies for regenerative medicine, is among the small group of companies that are conducting this type of study worldwide. In addition, Histocell provides a differential and unique treatment compared to other stem cell therapies.

HC016 cell therapy drug is based on stem cells obtained from adipose tissue that have been prepared with a unique process patented by Histocell and carried out in Histocell’s facilities.

Histocell has already entered phase II of the clinical trial, to demonstrate the efficacy of the drug. The promising results make the company face the new phase with optimism. The objective is to develop and finish phase II throughout 2021, obtaining effective results.

Phase II is a controlled, randomised and double blind. It is expected to expand the number of hospitals participating in this phase to speed up the process.

Histocell, more than 50 registered patents

Histocell was established in 2004 with the mission of developing new medical devices and cell Therapy drugs in the field of regenerative medicine.

Histocell has two main production facilities. The headquarters that include a cell therapy drug manufacturing unit, certified by the Spanish Agency for Medicines and Health Products, and a medical devices and dermocosmetics manufacturing plant.

Histocell’s products are backed by strong intellectual protection, with more than 50 patents registered in major world markets.