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Regenerative
Research in China Targeting COVID-19 Gains MomentumâEvidence of Some Success
and an American Venture
Mar 23, 2020 | Coronavirus, COVID-19, Investor Watch, Mesenchymal Stem Cells, News, Regenerative Medicine, Stem Cell, Stem Cell Therapy | 0 comments
Worldwide
researchers and clinical investigators develop vaccines, therapeutic treatments
and diagnostic tests to take on COVID-19 and in China in addition to these
activities some physicians are declaring some initial success utilizing stem
cell therapy. Could this approach represent a possible treatment and ultimate
cure in the future? TrialSite News cautions hereâregenerative medicine
represents great potential and possible peril. But a regenerative therapy
movement appears to be gaining steam.
Enter Dr.
Dongcheng Wu
Based in Wuhan, Chinaâthe place where
the pandemic startedâDr. Dongcheng Wu reports he
has treated, successfully, nine critically ill and hospitalized patients
fighting COVID-19 pneumonia. Struggling with dangerous lung inflammation and
serious breathing problems, the patients volunteered for experimental
injections of Mesenchymal stem cells (MSCs) derived from human umbilical cords
reports Pain News Network. According to this article, the
Wuhan-based physician, all of the patients recovered within days. If this is
true it could this milestone represent a material data point for the potential
of regenerative medicine in the fight against COVID-19?
The
Sponsor: Blue Horizon International (BHI)
Apparently, Dr. Wu is the chief science
officer for New York-based Blue Horizon International (BHI). Founded
in 2009 by Brian Mehling, MD, on his
vision focusing on a future in which stem cell therapy and regenerative
medicine become the preferred treatment over many surgical, pharmacological and
rehabilitative medical services. Dr. Mehling, an American orthopedic
trauma surgeon practicing in both New York and New Jersey, became intrigued
with this technology and its potential to disrupt the healthcare market while
studying biochemistry during his residency, reports his website. His firm,
BHI, specializes in bringing quality stem cell, regenerative, and related
biologic technologies to emerging and established markets in a safe and ethical
manner.
Preclinical
Research
BHI conducted research, including preclinical animal
research and found that MSC cells migrated to the lungs where they materially
reduced inflammation and repaired damaged tissue.
Over a
Dozen Stem Cell-based Clinical Trials Targeting COVID-19 in China
Back in China, BHI is sponsoring a
clinical trial focusing on COVID-19 patients. They are seeking 48 participants
for a placebo-controlled study of MSC injections. According to the Pain News Network, BHIâs study is not the first to
employ stem cells to treat COVID-19 patients. The South
China Morning Post reports over a dozen clinical trials ongoing in
China using stem cells as a treatment for COVID-19.
The Stem
Cell Therapy Trend Gains Momentum in China
There is a growing community of
physicians and clinical researchers in China that believe stem cell therapies
can provide treatment options for COVID-19 patientsâthere is a growing
discussion in the Chinese medical community about stem cells as a treatment for
SARS-CoV-2.
A recent study published in the
journal Aging
and Disease discussed a
study, conducted by dozens of prominent Chinese and international
investigators, representing multiple research centers, showcasing that stem
cell therapy treatments can actually âcure or significantly improveâ COVID-19
patient symptoms.
More
Experimental Regenerative Interest & COVID-19
Interestingly, another firm, Celltex Therapeutics, based in
Texas, recently requested that the U.S. Food and Drug Administration (FDA)
grant permission for this firm to conduct a clinical trial within America on
the safety and efficacy of stem cell treatment for COVID-19. Founded in
2011 by Dr. Stanley Jones, this
regenerative medicine focused firm has raised $34 million in venture capital.
Stem Cell
Industry Concerns
TrialSite
News has
written about some of the concerns with this promising but emerging and, in
most cases, highly experimental approach. For example, in Stem Cell Research: Promise and Possible
Peril, the darker side of this emerging practice is also
showcasedâmultiple deathsâand operations preying on desperate patients in
search of cures where there were none. The U.S. Food and Drug Administration (FDA)
continues to warn Americans that some patients may be vulnerable to
stem cell treatmentsâmany of which are found to be illegal and potentially
harmful. In the TrialSite News article, FDA-approved stem cell therapies were listed. Consumers
and patients should check with their physicians and even consult the FDA website on
approved treatments. Of course, this cautionary tale doesnât apply directly to
BHI but rather is inserted to remind and raise awareness as to the risks
associated with operations that are not explicitly approved by the FDA or
comparable authorities in other countries.
BHI
Research: Moving Regenerative Research Forward
Blue Horizon International has set up
BHI Therapeutic Sciences Inc. (BHITS) for the inclusion of investors in their
research enterprise; they also have a sister organization, formed in 2010 in
Switzerland called Blue Horizon International AG (BHIAG). BHITS was set up to
undertake research and âmonetizeâ stem cell technology and associated
regenerative medicine. They declare on their website that this research
group is led by an âaccomplished science and medical teamâ and engages with
international partners with experience treating thousands of patients utilizing
this regenerative technology. Moreover, in 2018, they opened a treatment and
trial clinic in Houston, Texas, in a quest to expand their stem cell therapy
research in America.
The company declared that its Swiss
venture (BHIAG) has successfully treated 100 research subjects with chronic
inflammation, 30 subjects with spinal cord injury and 97 stroke patients by
employing ethically harvested human umbilical cord blood derived stem
cells. TrialSite News could not verify this via third
parties. Additionally, the firm reports that it treated 350 research
subjects with musculoskeletal disorders with the application of human adipose
tissue derived stem cellsâbut it isnât clear A) where this research occurred;
B) if it was approved by regulatory authorities; or C) if there are any
published results.
Published
Clinical Trial
TrialSite
News research
was able to validate a website claim that the company had engaged the FDA for a
forthcoming clinical trialâwe identified one clinical trial that appeared to be
FDA-approved and published on the governmentâs Clinicaltrials.gov website.
The study evaluates the safety and efficacy
of hemacord HPC, cord blood in patients with acute ischemic stroke. The
Phase I study investigates the safety and efficacy profile of allogeneic cord
blood hematopoietic injection, in patients who have sustained an acute ischemic
stroke within the past 9 days. The study treatment period consists of 3
sessions including both intravenous infusion and intrathecal injection (or
intravenous infusion in conjunction with mannitol for patients unable to
tolerate intrathecal injection). The sponsor then does follow up phone calls
monitoring for adverse events (AE) assessment at the first week, first month
and two months after the first treatment. The patient comes for a follow up
clinic visit at month three and month six and then month 12 which also includes
a neurological exam, MRI and clinical laboratory tests/urinalysis.
This published study will involve 10
patients and is planned to start September 2020 and conclude July 2022. Dr.
Mehling services as the principal investigator.
Dr. Brian
Mehling Profile
Dr. Mehling (founder of both BHITS and
BHIAG) declares on his companyâs website to be a âglobally recognized presence
in the regenerative medicine research community,â having founded a number of
companies in Germany, Slovakia, Jamaica, Brazil, Seychelles, and Israel with
plans for Monaco, Germany and Israel. Based on the news of today, we know he is
active in China. He declares that these firms only use adult (somatic)
stem cells and human umbilical cord blood stem cells ethically harvested from
umbilical cords collected after birth. They donât, however, publish the ethical
supply chain for such inputs which would be of use.
Call to
Action: BHI declared
on its website that it is interested in investment. See the link to review in more detail. The
regenerative medicine movement grows, and Dr. Mehling is positioned as a global
expert. For those interested in this approach, it canât hurt to do some
more research.
· Source: Pain
News Network