Hope Bio’s stem cells zero in on Crohn’s Disease

Inspired by results in other autoimmune conditions

By Jan Shultis

Billions of stem cells manufactured through proprietary technology by Houston-area biotechnology company Hope Biosciences have the regulatory “green light” to join the fight against Crohn’s Disease.

The U.S. Food and Drug Administration (FDA) has authorized a Phase II clinical trial to evaluate whether the stem cells manufactured through Hope’s proprietary technology affect signs and symptoms of Crohn’s Disease in suffering people. With an established and rapidly expanding portfolio of effectively addressing inflammation in autoimmune conditions (click here for work in Rheumatoid Arthritis, and here for news about multiple sclerosis), the team at Hope is just that – hopeful.

Catch an overview of mesenchymal stem cell therapy on an early episode of Hope Bio's "Stem Cell Revolution" podcast.

“We are eager to see our technology positively impact the lives of people in need, and several things about what we do and how we do it make me believe in this solution,” elaborates Donna Chang, CEO, Hope Biosciences. “For example, people living with Crohn’s are often restricted in their ability to travel or move around in the world due to the nature of their symptoms. Looking ahead, our ability to ship our cellular therapeutic to a patient’s location, or even administer in-home, may play a vital and practical role in making treatment available. Pending positive outcomes of this trial – about which we are optimistic, given past success in dramatically lowered inflammatory markers in clinical trials in other autoimmune conditions – it is straightforward to envision a path toward delivering relief.”

Hope Biosciences Research Foundation (HBRF), headquartered in Sugar Land, Texas, will serve as the clinical trial site for a balanced randomized, double-blind, placebo-controlled trial.

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During a sixteen-week treatment period, participants will receive six infusions of 200 million allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) or a placebo. There is no treatment cost to participants; travel costs to the clinical trial site, however, are not covered. Participants can be male or female, aged between 18 and 65 years. By the time of the trial enrollment screening visit, at least six months must have passed since diagnosis. Crohn’s Disease Activity Index (CDAI) scores at screening must indicate mild- to- moderate Crohn’s Disease. The trial is enrolling and is listed on clinicaltrials.gov.

For up-to-date clinical trial information, please visit hopebio.org, or reach out directly to HBRF’s by writing to clinical@hopebio.org or calling (346) 900-0340.

Unless in direct relationship with someone living with Crohn’s, informal inquiry reveals a generally low level of public awareness about the condition. Knowing more, however, underscores the importance of researching cell therapy in Crohn's as a possible method of illuminating solutions for a far wider array of autoimmune conditions. Currently considered “incurable” and of undetermined cause, Crohn’s Disease is a form of irritable bowel disease (IBD), a category of inflammatory diseases that also includes ulcerative colitis. In Crohn’s, chronic inflammation of the digestive tract can create sufficiently severe pain and uncontrolled diarrhea that sustained fatigue, malnutrition, and weight loss become urgent physical concerns often leading to other health challenges.

Crohn's Disease can affect any part of the gastrointestinal tract, but most commonly afflicts the colon and intestine.

In practical terms, it is straightforward to imagine the associated implications of Crohn's symptoms on social and professional life; numerous studies report a high occurrence of depressive symptoms among those living with Crohn’s. According to the Center for Disease Control, an estimated one million people in the United States live with Crohn’s, with the wider prevalence of IBD likely exceeding three million. Annual healthcare costs approach $3 billion in this country. The economic burden on individual households that include someone living with Crohn’s can exceed $30,000 annually, notwithstanding workforce impact in the form of lost or restricted capacity to work.

HBRF's press release announcing FDA authorization emphasizes HB-adMSCs as a novel therapeutic approach with potential to address the underlying drivers of inflammation rather than simply masking symptoms. Controlling symptoms is overwhelmingly the focus of currently available conventional therapies, which may include a combination of anti-inflammatory medications such as steroids, immunomodulating pharmaceuticals, nutritional modification, and/or surgical intervention. HBRF’s trial will primarily measure changes from baseline in Crohn’s Disease Activity Index (CDAI), a comprehensive clinical tool used for many decades to assess disease severity. The CDAI considers, among other components, number of liquid or loose stools, severity of abdominal pain, general well-being, reliance upon medication, presence or absence of abdominal masses, hematocrit level as measured by blood tests, body weight changes, and the presence or absence of fever.

“Though this trial constitutes our first official trial in any form of irritable bowel disease, we have seen the symptoms associated with this kind of condition improve in people who seek out Hope Bio for other forms of autoimmune disease,” expounds Chang. “We remain hopeful and look forward to first helping people in need, then sharing results to benefit the Crohn's and autoimmune community.”