A Look Back at 2023 with Hope Biosciences Research Foundation

Whether your relationship with an organization is as a beneficiary, participant, supporter, or official cheerleader, one of the best parts of the end-of-year period is receiving the “year in review” updates. It is a thrilling and joyful thing, to see laid out in concise summation milestones and successes that directly impact you.

Clinical research is no different. At Hope Biosciences Research Foundation (HBRF), we believe everyone has a role in delivering hope for healing from degenerative disease and illness. HBRF strives daily to unlock the potential of regenerative medicine, bringing new hope to people in need by dramatically accelerating clinical research in the United States. A non-profit 501 ©3 organization headquartered in Sugar Land, Texas (west of Houston, only 20 minutes by car from the world’s largest medical complex), HBRF works primarily with chronic degenerative conditions conventionally considered “incurable,” or that fall outside the parameters of traditional clinical research. HBRF is closing gaps in research and care by directly supporting patients while developing sustainable solutions with the potential to right our country’s currently crippled healthcare system.

The following updates, then, are deeply personal to us and to you. We ecstatically share that in 2023, HBRF:

· Administered nearly 100 billion stem cells, at no treatment cost to patients.

· Celebrated publication of four papers in peer-reviewed scientific journals, including pieces reporting positive outcomes in Parkinson’s Disease, “Long Haul” COVID, spinal cord injury, and cerebral palsy.

· Began or continued work in five Phase II FDA-authorized clinical trials, including three in Parkinson’s Disease, one in multiple sclerosis, and one in “Long Haul” COVID.

· Conducted twelve FDA-authorized expanded access protocols through the Compassionate Use Program, in Parkinson’s Disease, spinal cord injury stroke, primary lateral sclerosis (PLS), polyneuropathy, muscular dystrophy, palliative care, osteoarthritis, and Systematic Lupus Erythematosus (SLE). In 2023, HBRF became the first entity of which we are aware to receive FDA-authorization to administer stem cells to a juvenile patient with a rare form of drug-resistant epilepsy.[1]

· Release an in-house produced documentary, “Beyond Boundaries: A Journey to Walk Again,” on Thanksgiving Day. The film brings directly to viewers the real people behind a peer-reviewed piece published in Frontiers in Transplantation in December 2023, sharing improvements in neurofunction and quality of life of a 41-year-old quadriplegic man after several years of sustained, high-volume stem cell therapy administered by HBRF.

· Remained the only organization of which we are aware to conduct simultaneous FDA-authorized clinical trials in the same condition, using both autologous (one’s own) and allogeneic (donor) mesenchymal stem cells. Allogeneic research is extremely important in furthering access to cell therapies because treatments cultured from donor stem cells can be made faster and in larger quantities, reducing treatment cost and creating a strong foundation from which to reach global underserved populations.

· Enrolled nearly 1,000 new prospective patients in our proprietary, first-of-class electronic Patient Registry, for the second year in a row.

· Held HBRF’s first “Hope is Here” fundraising event, a luncheon attended by more than 200 community supporters.

HBRF was privileged to benefit from media engagement in 2023. Early in the year, Understanding Houston turned their spotlight on HBRF Founder Donna Chang for Women’s History Month. Later, the Solve ME/CFS Initiative (Solve M.E.) hosted HBRF President Donna Chang for a fall webinar. Solve M.E. is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long Covid and other post-infection diseases. The webinar offered a comprehensive discussion of findings from 3 HBRF-run studies in COVID prevention and treatment and 2 in Long Haul COVID and the potential for future studies in ME/CFS. Watch it, here:

Throughout the year, HBRF spoke directly to stakeholders through a monthly newsletter. Want to stay up-to-date on the latest Hope-filled news, without waiting until next year’s end-of-year update?! To subscribe, visit hopebio.org and enter your email address in the contact field at the bottom of the page. HBRF also produced a number of blogs on topics of interest. Most read include:

· What’s that word mean?! An intro to allogeneic cell therapy and why it matters

• PTSD and Clinical Research
• Metrics that Matter — Assessing Quality of Life in Clinical Research
• Cell Therapy “101”
• Tax Deductions, Good Works, and the Future of Healthcare
• In Loving Memory, with Hope: The story of “Mission Control” at HBRF

Also this year, nearly 1,000 people entered their information into the Client Registration Information System (CRIS) system, a first-of-class patient registry launched at the end of 2021 that allows potential patients to electronically complete pre-screening, while also creating an opportunity for HBRF to quantifiably and comparatively determine community areas of interest. Such a significant sustained response for the second year in a row is encouraging. HBRF looks forward to growing and refining the platform’s capacity to meet patient, researcher, and community needs.

Speaking of people, the HBRF team grew this year in two mission-critical roles, welcoming our first full-time sub-investigator, and our first dedicated office administrator. HBRF serves both patients and researchers, harnessing the power of collaboration to improve efficiencies and bridge gaps from bench to bedside. Growth in these two roles directly enhances our ability to do so.

As 2023 draws to a close, HBRF 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, and the work is only possible through community. Thank you, in no particular order, to the John S. Dunn Foundation, The Robert and Janice McNair Foundation, the Jimmy Pappas Sporting Clay Shoot, Hope’s Visionary Supporters, and all who gave this year. A special “thank you” to the Event Sponsor of this year’s “Hope is Here” luncheon, the Smith family, and to the Program Sponsor of the same, Titan Management.

Hope is built and sustained by communities, and that is certainly true at HBRF. Expressing our gratitude is an instance when words feel inadequate. We hope the work of the year speaks best.

What’s Next?

As the calendar year draws to a close, HBRF is recruiting for an FDA-authorized clinical trial in Parkinson’s Disease using allogeneic stem cells.

Looking ahead to 2024, HBRF continues to hold a special place in our heart for kids. We believe strongly in the potential of our research to empower future generations with regenerative solutions that change healthcare as we know it. Based on community needs as shared through HBRF’s first-of-class electronic Patient Registry, as of this writing the next two trials in the pipeline are in Cerebral Palsy (CP) and Juvenile Idiopathic Arthritis (JIA).

According to the National Health Institute, as many as 12,000 children born in the U.S. each year develop CP. The proposed FDA-authorized Phase II clinical trial will treat 24 children, at a projected cost of $1.7MM.

JIA affects approximately 300,000 children in the U.S. today. The proposed FDA-authorized Phase II clinical trial will treat 24 children, at a projected cost of $800,000.

As of this writing, HBRF works predominantly with a particular type of adult stem cell therapy, mesenchymal stem cell therapy, that since discovery 50 years ago has become one of the most widely studied cellular therapeutics by industry and academia, with an established and accepted safety profile. HBRF is focused on sustained high-volume administration of cells cultured to an unprecedented degree of cell viability. We are most intrigued by questions about how the stem cells we study will act in the body, to what degree, and over what period of time, because we believe answers to disease and injury lie there. HBRF’s emphasis constitutes a completely unexplored area of research and creates an opportunity to study MSCs at work in new disease conditions, with data-supported hope that an unprecedented degree of progress may occur in conditions commonly considered uncurable, including complete eradication of symptoms in some cases.

How YOU can help!

The end of the year is a time of increased charitable giving in the United States, as with it comes the end of accounting for current year personal taxes and most businesses. Many find charitable giving to a federally recognized 501(c)3 organization the ideal way to put hard-earned dollars to work doing good in a way that also benefits those who give. This year, we hope you will consider a tax-deductible gift to Hope Biosciences Research Foundation (HBRF).

Your gift matters. FDA-authorized protocols executed at HBRF are designed in-house to the highest scientific standards of safety and efficacy. Spanning a wide range of therapeutic areas, HBRF’s research suite demonstrates both the versatility of regenerative medicine and the capabilities of the HBRF team. HBRF assumes all treatment costs associated with the FDA-authorized protocols sponsored here, because we never want lack of personal funding to create a barrier to entry into clinical research for patients seeking the opportunity. That means your support goes directly to people in need.

Our appeal is simple — with more, HBRF can do more. Funds can be directed to the active study of your choice, or given for use where HBRF knows need to be greatest. Generally, a gift of:

* $100 secures infusion supplies.

* $250 supports a full day of operations in our infusion center.

* $750 administers a treatment.

* $75,000 ensures a year’s worth of treatment under Compassionate Use.

* $250,000 provides 60 treatments in a clinical trial.

* $2MM initiates a new clinical trial for an indication of choice.

* $4.7MM completes all current Compassionate Use and clinical trials in progress.

Donations to HBRF can be made in-person at our Sugar Land location (16700 Creek Bend Drive, Sugar Land, TX 77478), by check mailed to the same address (16700 Creek Bend Drive, Sugar Land, TX 77478), or online at hopebio.org/donate.

Again, your gift is tax-deductible; HBRF is a federally recognized 501(c)3 organization, EIN 84–3802908. Click here to learn more about why your gift matters and who it helps, legacy giving and giving for Compassionate Use, plus two ways to give that maximize your tax benefit.

And mark your calendars for October 26th, 2024, please! That night, Hope heads to the Post Oak Hotel for an evening of celebration you won’t want to miss.

Thank you for supporting Hope, by giving hope.

We hope you are as delighted as we, by 2023. As we all plunge into 2024 with gusto, there is nowhere we would rather be than right here, with you, with hope.

[1] To date, 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 epilepsy; as well as immune conditions such as lupus; chronic musculoskeletal pain, severe osteoarthritis, and psoriatic arthritis; and pancreatic cancer. Since opening the doors in March 2020, HBRF has administered more than 220,000,000,000 stem cells at $0 cost to patients.