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AustraliaâÂÂs Mesoblast plans to evaluate
its stem cell therapy in patients infected with COVID-19
March 11, 2020
By Tamra
Sami
PERTH, Australia â Australian stem cell
therapy company Mesoblast Ltd. plans to evaluate its
allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients
with acute respiratory distress syndrome (ARDS) caused by coronavirus
(COVID-19) in the U.S., Australia, China and Europe.
The company is in active discussions with
various governments, regulatory authorities, medical institutions and
pharmaceutical companies to implement these activities.
âÂÂWhat people are dying of is acute
respiratory distress syndrome, which is the bodyâÂÂs immune response to the virus
in the lungs, and the immune system goes haywire, and in its battle with the
virus it overreacts and causes severe damage to the lungs,â Mesoblast CEO
Silviu Itescu told BioWorld.
âÂÂWeâÂÂre going to be evaluating whether an
injection of our cells intravenously can tone down the immune system just
enough so it gets rid of the virus but doesnâÂÂt destroy your lungs at the same
time.âÂÂ
Recently published results from an
investigator-initiated clinical study conducted in China reported that
allogeneic MSCs cured or significantly improved functional outcomes in all
seven treated patients with severe COVID-19 pneumonia.
Silviu Itescu, CEO, Mesoblast
âÂÂWe have now looked at our own data in
lung disease in adults where half the patients had the same kind of
inflammation in the lungs as you get with coronavirus, and our cells
significantly reduced the inflammation and significantly improved lung
function,â Itescu said, noting that he is awaiting emergency use authorization
to treat patients under a clinical trial protocol.
In a post-hoc analyses of a 60-patient
randomized controlled study in chronic obstructive pulmonary disease (COPD),
remestemcel-L infusions were well-tolerated, significantly reduced inflammatory
biomarkers, and significantly improved pulmonary function in those patients
with elevated inflammatory biomarkers.
Since the same inflammatory biomarkers are
also elevated in COVID-19, those data suggest that remestemcel-L could be
useful in the treatment of patients with ARDS due to COVID-19. The COPD study
results have been submitted for presentation at an international conference,
with full results to be submitted for publication shortly.
Mortality in COVID-19-infected patients
with the inflammatory lung condition is reported to approach 50% and is
associated with older age, co-morbidities such as diabetes, higher disease
severity, and elevated markers of inflammation.
Current therapeutic interventions do not
appear to be improving in-hospital survival, and remestemcel-L has potential
for use in the treatment of ARDS, which is the principal cause of death in
COVID-19 infection.
Itescu said he didnâÂÂt know of any other
stem cell companies that were doing this. He said that other companies could
try the approach from a research perspective but that Mesoblast has all the
patents locked down.
The companyâÂÂs intellectual property
portfolio encompasses more than 1,000 patents or patent applications in all major
markets and includes the use of MSCs obtained from any source for patients with
ARDS, and for inflammatory lung disease due to coronavirus (COVID-19),
influenza and other viruses.
Remestemcel-L is being studied in numerous
clinical trials across several inflammatory conditions, including in elderly
patients with lung disease and adults and children with steroid-refractory
acute graft-vs.-host disease (aGVHD).
MesoblastâÂÂs stem cell therapy is currently
being reviewed by the FDA for potential approval in the treatment of children
with steroid-refractory aGVHD. The company submitted the final module of
a rolling BLA in January.
Remestemcel-L is being developed for rare
pediatric and adult inflammatory conditions. It is an investigational therapy
comprising culture-expanded MSCs derived from the bone marrow of an unrelated
donor and is administered in a series of intravenous infusions.
The stem cell therapy is believed to have
immunomodulatory properties to counteract the inflammatory processes that are
implicated in several diseases by down-regulating the production of
pro-inflammatory cytokines, increasing production of anti-inflammatory
cytokines, and enabling recruitment of naturally occurring anti-inflammatory
cells to involved tissues, according to Mesoblast.
CoronavirusAustraliaBioWorldClinicalCell therapyInfectionInflammatoryRespiratory
Keywords Australia coronavirus COVID-19 Mesoblast Ltd. Remestemcel-L stem cell
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