Here for the Long Haul
A 2024 update on HBRF’s work in Long COVID
While talk of new things in a new year is invigorating, there can be great value in declaring that part of what a new year offers, is the chance to continue the work of the preceding year. Hope Biosciences Research Foundation’s (HBRF) suite of FDA-authorized research in COVID-19 and “Long Haul” COVID, is one such area. Now in its fourth year, HBRF’s COVID research represents our longest-running endeavor, and one still in vital demand in our community.
Status of HBRF’s COVID research
To date HBRF has obtained FDA authorization for five clinical protocols using mesenchymal (adult) stem cells cultured by Hope Biosciences through their proprietary technology, including three Phase II clinical trials in COVID-19 prevention and treatment, and one Intermediate Size Expanded Access and one Phase II clinical trial in “Long Haul” COVID. The first three studies encompassed treatment and prevention, including a specialty study for law enforcement and front-line healthcare workers. All three are complete. The fourth protocol, authorized by FDA in February 2021 and completed in 2023, became the nation’s first stem cell study in “Long Haul” COVID, in direct response to appeals for help from those suffering. The fifth, also in Long COVID, recently concluded treatment of 80 patients and moves now to data analysis.
Included in the COVID research suite are allogeneic protocols, which means using stem cells from carefully selected donors. In addition to helping afflicted individuals, these protocols represent what HBRF hopes is a significant contribution in increasing regulatory acceptance of allogeneic adult cell therapies. Allogeneic therapies, with their dramatically reduced costs for manufacturing stem cells and potential to make larger quantities of cells, faster, to a comparable safety profile, represent a potentially powerful way for ensuring equitable and timely access to cell therapies in the future.
Peer-reviewed pieces published in recent months share promising results. A December 2023 piece in Frontiers in Medicine demonstrates that even in the most acute patient population treated with HB-adMSCs, individuals hospitalized for active COVID complications at the height of the pandemic, the drug was shown safe. A September 2023 piece in Stem Cell Research & Therapy indicates that treatment with autologous HB-adM SCs resulted in significant improvements in the signs and symptoms associated with post-COVID-19 syndrome as assessed by various clinical scoring systems. Patients also reported significant improvements in quality-of-life. Again, administrations of multiple infusions of HB-adMSCs were proven safe.
With treatments complete in all five FDA-authorized protocols, as of this writing no drug-related safety or serious adverse events have been experienced by participants. Observed and documented experiences include improved energy, reduced pain, improved cardiovascular capacity, and return of normal daily functions. In participants’ own words:
“Thank you so much. I’m a first wave long hauler… my qualify of life has been improved so much.”
“Visiting Hope Biosciences’ facility and meeting these real and wonderful people it’s definitely epic and moving at the same time. Just the thought of having a life altering experience is super exhilarating. Prayers for continued successful results.”
“Thank you for this groundbreaking treatment which gave me a second chance at life I thought I would never have! The taste of air in my lungs after one year of suffering I remember as if it was my first breath as a newborn. Unbelievable results I’m living again, all because of Hope Biosciences and their beautiful commitment to helping humanity.”
HBRF looks forward to continuing to share results.
Background
Coronavirus disease 2019 (COVID-19) is a highly contagious respiratory disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). Declared a pandemic by the World Health Organization in March 2020, as of 7 March 2021, date of the most readily available census, there were already more than 100 million cumulative cases, and more than 2.5 million deaths worldwide. The United States counts nearly 30 million cumulative cases, with more than half a million deaths attributed to COVID.
Estimates range, but anywhere from 2.5% to 25% of adults who contract COVID develop “Long COVID.”[1] Also referred to as “Long Haul COVID,” “Post-COVID-19 Syndrome,” or “Chronic COVID,” the condition denotes a constellation of symptoms persisting for at least four weeks after initial infection; symptoms can include fatigue, shortness of breath, cough, headache, body aches, and loss of taste and smell, among others. As of this writing, there is no established case definition or diagnostic criteria for Long COVID. Studies differ in how they define the condition, creating the sizable discrepancy in estimated percentage of those afflicted.
Long COVID’s impact
While the financial, social, and communal costs of COVID infection are increasingly well documented, the toll of long COVID is difficult to measure. Various mechanisms for Long COVID proliferation are assumed, including genetic and environmental considerations that vary dramatically between locations.[2] It is equally or more difficult to compare findings across what studies are conducted, because research groups may choose to focus on varied definitions and symptoms, or survey different groups of people.[3] It is certain that Long Haul COVID represents a significant burden on our country’s medical, social, and financial systems, affecting our nation’s workforce, families, hospitals, and communities.
“It affects people across the lifespan, from children to older adults, and across demographic groups,” clinical epidemiologist Dr. Ziyad Al-Aly told the Committee on Health, Education, Labor and Pensions (HELP) during January 2024 Congressional hearings on COVID. “The burden of long COVID, the burden of disease and disability when you measure it, is on par with the burden of cancer and heart disease,” Al-Aly continued.[4]
Governmental efforts to date are widely criticized for their enormous price tag and lack of results. Patients are particularly frustrated with continued governmental funding of mechanistic research that yields little to no practical benefit for suffering people.
Looking ahead
Long COVID research matters for its promise to affect healing not only in this population, but for people suffering from conditions that act much like Long COVID in the body. Early reports from studies with patients with long COVID suggests symptomology similar to another chronic medical illness — myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).[5] ME/CFS is a long-term complicated illness characterized by at least six months of fatigue and exhaustion. Estimated to account for anywhere from $18–51 Billion dollars in care and lost workforce potential, more than 2.5 million Americans suffer from chronic fatigue syndrome. Of those, approximately a quarter are confined to their beds or homes. Within the general population, the prevalence of chronic fatigue ranges between ten and forty percent. Despite the staggering numbers, both Long COVID and ME/CFS patients often report frustration with lack of diagnostic criteria and resultant disbelief of ailment from physicians, further pointing to the need for continued work in these areas.
“We exist to fill demonstrated community needs, and our COVID work is a reflection of that commitment,” says Donna Chang, President, HBRF. “Ours is a comprehensive research suite that explores the safety and effectiveness of proprietary mesenchymal cell therapy in patient populations throughout the spectrum of severity, in both COVID-19 and Long COVID, using both autologous and allogeneic cell therapy treatments. Consistency of results is encouraging not only for this investigational product and disease state, but also for other conditions that may act similarly in the body, such as chronic fatigue syndrome. We have only just begun.”
Wherever the path ahead, where there’s a need, HBRF is here for the long haul.
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Founded in 2020 and headquartered in Sugar Land, Texas (west of Houston), in its third year of operation Hope Biosciences Research Foundation remains the only entity in the world exploring the effects of high volume, sustained application of stem cells on diseases and conditions that currently have no cure and affect substantial portions of the American population. HBRF’s strategic goal is to advance FDA-regulated biotechnology in the United States, meeting the treatment needs of suffering people while developing affordable, accessible, sustainable healthcare solutions. To date HBRF has obtained FDA authorization for more than 35 clinical protocols. Clinical trial authorizations encompass COVID-19 prevention and treatment, “Long Haul” COVID, Parkinson’s Disease, and multiple sclerosis (MS). Expanded access protocol authorizations include nervous system conditions such as amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), cerebral palsy, spinal cord injury, polyneuropathy, muscular dystrophy, and drug-resistant epilepsy; as well as immune conditions such as lupus; chronic musculoskeletal pain, severe osteoarthritis, and psoriatic arthritis; stroke; palliative care; and pancreatic cancer. Research is conducted at no treatment cost to participants. Learn more at hopebio.org.
[1] From CNN Health, February 2024, https://www.cnn.com/2024/02/12/health/long-covid-pregnancy-children/index.html
[2] “Long COVID is a double curse in low-income nations: here’s why.” Nature. Jan 3, 2024. https://www.nature.com/articles/d41586-023-04088-x
[3] “Long COVID is a double curse in low-income nations: here’s why.” Nature. Jan 3, 2024. https://www.nature.com/articles/d41586-023-04088-x
[4] As reported in Fortune, https://fortune.com/2024/01/24/experts-patients-warn-congress-long-covid-government-blows-through-billion-cure-health-carolyn-barber/
[5] Wong TL, Weitzer DJ. Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)-A Systemic Review and Comparison of Clinical Presentation and Symptomatology. Medicina (Kaunas). 2021 Apr 26;57(5):418. doi: 10.3390/medicina57050418. PMID: 33925784; PMCID: PMC8145228.
