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 here—regenerative medicine represents great potential and possible peril. But a regenerative therapy movement appears to be gaining steam.
Enter Dr. Dongcheng Wu
Based in Wuhan, China—the place where the pandemic started—Dr. 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.
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, BHI’s 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 patients—there 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 “cure or significantly improve” 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 showcased—multiple deaths—and 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 treatments—many 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 doesn’t 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 “monetize” stem cell technology and associated regenerative medicine. They declare on their website that this research group is led by an “accomplished science and medical team” 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 cells—but it isn’t 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 trial—we identified one clinical trial that appeared to be FDA-approved and published on the government’s 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 company’s website to be a “globally recognized presence in the regenerative medicine research community,” 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 don’t, 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 can’t hurt to do some more research.