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The Leo Effect:

Why Hope Biosciences’ most recently published work in cerebral palsy matters to us all | Written by Jan Shultis



At Hope Biosciences, we culture every one of your stem cells by hand. This work matters to us as a strategy for sustainable customized medicine in the United States, as a biotechnology solution to health problems plaguing our communities, and on a very personal level as service to individuals who trust us with their stem cells.

A glimpse into Leo's life.

Personal caring is, we believe, the essence of translational medicine (“translational medicine” can be generally thought of as work to bring scientific discoveries and technologies from the lab to people who need them). This month it is a privilege to share a peer-reviewed publication chronicling Hope Bio’s work with one individual whose story has come to epitomize that kind of caring to our team – Leo, a young man with severe cerebral palsy. When we met him in 2017 Leo was bedridden, hovering around 50 lbs bodyweight as a young teenager, suffering from severe scoliosis and other associated complications. Leo looks different now – over the course of many treatments of stem cells cultured by Hope Biosciences through an FDA-authorized Expanded Access protocol he more than doubled his bodyweight, enabling him to have life-changing scoliosis surgery. We saw his hair grow long and thick, and that grin grow even stronger, among other progress.

The sweetest smiles during Leo's infusion.

It is a bit unusual for cell culture teams to have such a window into the lives of the people they serve. Hope Biosciences is, however, fortunate to be geographically located with the clinical research organization that today carries out much of the research conducted with Hope Bio’s stem cells. Hope Biosciences Research Foundation (HBRF) was established during the course of Leo’s three-year treatment protocol. Today HBRF is the primary clinical research organization through which stem cells cultured by Hope Biosciences are studied in individuals like Leo, who do not otherwise qualify for FDA-authorized clinical trials. Though conducted to the same degree of rigor as a larger clinical trial, with the same clinical practice standards and reporting requirements as a clinical trial and comparable per-patient burden of time and money to administer, Expanded Access Protocols are not accepted by FDA as a vehicle for gathering data. The stance is puzzling, particularly because Expanded Access authorization can be granted for individuals or small groups – how is what we learned from Leo less important than something learned from a patient in a clinical trial with more participants? While we like to think that the regulatory bodies have defensible reasons, the practical impact is often one of grounding, stalling, or completely halting promising research. This is also why Leo’s results are published in the form of a “case study.”


Leo soaking up the love from his wonderful family.

During every hand-cultured treatment manufactured for Leo, we thought about him and his family, wondering how his story would unfold. The peer-reviewed piece in the International Journal of Stem Cell Research & Therapy is an important part of sharing the answers with the world, but can make for daunting reading for non-scientists. In summation, the paper finds:

  • Multi-dose treatment with autologous stem cells cultured by Hope Biosciences’ proprietary methods (referred to as “HB-adMSCs”) may offer a safe and effective way to improve quality of life in patients with cerebral palsy. They did for Leo, who as previously mentioned more than doubled his body weight as a result of cell therapy; previous around-the-clock tube feeding had resulted in no weigh gain.

  • Owing to their immunomodulatory and regenerative capabilities, MSCs may constitute a promising approach to “failure to thrive” cases in a variety of disease conditions. “Failure to thrive” is a term generally used to refer to children who fail to gain weight or grow to medical standards. Sometimes causality is linear; sometimes the causes are unknown. Leo’s reasons were mixed – yes, he had severe diagnosed medical conditions that impact all bodily functions. But, he should have been gaining weight through tube-feeding, a direct response to those unique medical conditions, and when we met Leo, he was not.

  • Noticeable improvements were seen in Leo's neurological state, including measurable rectification of visual impairment and noticeable decline in involuntary movements. Over the course of the three-year protocol, Leo demonstrated greater ability to interact with those around him, including through language, and including but not limited to indicating his preferences and desires, calling for his parents, and communicating with the aid of a computer.


Leo doing what he does best, bringing joy to HBRF's Clinical Team.

We are proud that stem cells we manufactured had and have such an impact on Leo’s life. Looking ahead to our mission and vision as an organization, here’s how this case study matters to each of three sectors previously mentioned:

As a strategy for sustainable customized medicine in the United States, Leo’s story demonstrates the scalability of mesenchymal stem cell therapy, of which financial burden is a component. The Centers for Disease Control (CDC) reports the annual cost of care for a child with cerebral palsy at approximately $45,000, and well in excess of $1M over the course of the child’s lifetime. HB-adMSC treatments are far less, even considering many years of administration, such as occurred in Leo’s case.

As a biotechnology solution to health problems plaguing our communities, we now know that long-term treatment with HB-adMSCs can yield benefits in cerebral palsy. Cerebral palsy is the most common motor disability in childhood, according to the CDC, and affects nearly one million people in the United States today. Leo’s experience confirms a larger body of data validating the use of MSCs in neurological conditions, including recent and on-going work with HB-adMSCs in traumatic brain injury (TBI), while extending findings in new and promising ways.

On a very personal level as service to individuals who trust us with their stem cells, Leo’s story provides a roadmap for accessing cell therapy, and illustrates why banking stem cells at birth is so important. Many members of the Hope Bio team are parents, and we never like to discuss healthcare in “doom and gloom” terms. The bottom line remains, however, that should something unforeseen happen in the life of a baby or child, we find it a comfort to know that cell therapy with HB-adMSCs is immediately an option, if that child’s stem cells were banked at birth.

In case you missed it at the beginning of our conversation and the summation has sparked a desire to read the piece in full, you’ll find Leo’s detailed case study here, in the International Journal of Stem Cell Research & Therapy. Thank you, Leo, and all the “Leo’s” we know and have yet to meet, for trusting us. You are forefront on our minds this and every day. It remains a privilege to know and serve you.


 


About Hope Biosciences

Hope Biosciences is a biopharmaceutical company developing adult stem cell therapeutics for a variety of clinical indications, and the only clinical grade adult stem cell banking facility in the nation serving both adults and newborns. Hope Biosciences occupies a unique position in the regenerative medicine space, noteworthy both for patented cell culture methods and effectiveness getting cells to patients through robust collaboration with academic and clinical research organizations. Hope Bio’s proprietary cell culturing process makes Hope Biosciences the gold standard in producing high volume, consistent, repeatable mesenchymal stem cells for clinical purposes, and Hope Biosciences actively partners with organizations and teams in need of cellular products for in vitro, preclinical, and clinical projects.

Learn more about Hope Biosciences at www.hope.bio.



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