During the autumn, Xintela has investigated whether the company’s selected stem cells, XSTEM, can be used for the treatment of Acute Respiratory Distress Syndrome (ARDS), a life-threatening lung complication that affects some Covid-19 patients. The company has completed the majority of the preclinical study, and so far, it has given promising results. They have seen a clear improvement in lung function after the XSTEM treatment and a reversal of the critical ARDS condition – something that is very difficult to achieve with current treatments.
During the spring, Xintela was granted 1 Mkr from the innovation authority Vinnova in the call for “Innovations in the wake of the crisis – Restructuring of society, operations and production in the wake of the corona epidemic.” A total of 270 projects applied for the grant, but only 18 applications were awarded, including Xintela’s, which received the maximum amount.
The grant concerned the funding of a preclinical study to evaluate Xintela’s stem cell, XSTEM, for the treatment of Covid-19 patients with the fatal disease condition ARDS (Acute Respiratory Distress Syndrome). Although the study is not yet completed, they have been able to see positive results regarding XSTEM’s therapeutic effect in ARDS according to Xintela’s CEO Evy Lundgren-Åkerlund:
»We have successfully completed the major part of the study and the results are very promising. In all animals treated with XSTEM-ARDS, we see a clear improvement in lung function and a reversal of the critical ARDS condition. For logistical reasons, it will take some time before we can complete the study, so we have chosen to report the current status and results thus far of this exciting study.« – Evy Lundgren-Åkerlund, CEO Xintela
ARDS and today’s treatments
ARDS is a serious condition that is characterized by dyspnea (shortness of breath), tachypnea (high respiratory rate) and hypoxia (low oxygen concentration in the blood). The low oxygen content in the blood can make the skin turn blue (cyanosis) and deprive the organs of oxygen.
In Scandinavia, around 18 people are affected by ARDS for every 100,000 people each year. However, the incidence has most likely increased significantly in 2020 due to the Covid-19-pandemic. According to a study conducted at the Medical University of Vienna, the mortality rate in Covid-19-associated ARDS is 45 per cent.
Today, the primary treatment for ARDS is mechanical ventilation with a respirator along with treatments aimed at the underlying cause. For example, antibiotics may be needed if a bacterial infection is the cause to the ARDS.
Xintela stem cells potentially reduce the cytokine storm
Xintela’s mesenchymal stem cells, XSTEM, originate from donated adipose tissue and are selected with the company’s stem cell marker integrin α10β1. These cells have an immunomodulatory and anti-inflammatory effect that potentially can reduce the underlying inflammatory cytokine storm that leads to ARDS in some Covid-19 patients . This means that Xintela’s stem cells could potentially improve oxygenation in the lungs, thus reducing reliance on ventilators in the intensive care unit.
In collaboration with SUS
The preclinical study is being performed in collaboration with Professor Sandra Lindstedt and her team at the Cardio-thoracic surgery clinic at Skåne University Hospital in Lund and with Lund University. During the study, Xintela’s selected mesenchymal stem cells were used in a pig model of ARDS. Professor Lindstedt expressed her satisfaction with the positive results seen with Xintela’s stem cells in a recent press release:
»There is currently no effective treatment for ARDS. It is therefore encouraging to see the promising results with Xintela’s stem cells in a model that is clinically similar to the life-threatening lung complication in ARDS patients. The results show that XSTEM-ARDS has the potential to improve the severe condition in ARDS patients, which can shorten intensive care time and reduce mortality« –Sandra Lindstedt, Professor Lund University
Improvement in the lung function
The study involves twelve animals with the lung complication ARDS. Six of the animals receive intravenous treatment with XSTEM-ARDS and the remaining animals are control subjects that received or will receive an injection without Xintela’s stem cells. During the study, various clinical parameters are being monitored to measure lung and circulatory function along with the general health status of the animals. In addition, blood and tissue samples are collected and will be analyzed when the study is completed.
The results so far show that XSTEM-ARDS had a positive therapeutic effect in all four animals that have received the stem cells, so far. The lungs’ ability to oxygenate blood was improved, and a stabilsation of the blood circulatory system had occurred. No improvement has been observed in the control animals.
Clinical study in patients with Covid-19
The overall goal of the preclinical study is to demonstrate that Xintela’s stem cells are safe and effective to use against ARDS. Today’s announcement means that Xintela has taken an important step towards that goal, however, two animals still need to undergo treatment before the final results can be compiled.
In case of a final positive result, Xintela will use it as a basis for an application to the Medical Products Agency for conducting clinical studies with Xintela’s stem cells in Covid-19 patients with ARDS, in hopes of being able to help a patient group that currently lacks adequate treatment.
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