Hope Biosciences Stem Cell Research Foundation Secures Authorization For “Long Haulers” Covid Study

Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) gained Federal Drug Administration (FDA) authorization Friday for the nation’s first stem cell study of Post-COVID-19 Syndrome.

The ten-patient study will evaluate the effectiveness of mesenchymal stem cell therapy on COVID-19 patients who continue to display symptoms long after they have recovered from coronavirus. These so-called “long haulers” can exhibit symptoms anywhere from three- to more than twelve weeks after recovery from the virus. Active symptoms can include fatigue, shortness of breath, cough, headache, body aches, and loss of taste and smell, among others.

“I am incredibly proud of our team,” says HBSCRF Founder Donna Chang. “COVID first hit our community the same week HBSCRF marked its official opening. Our physicians, nurses, and support personnel immediately shifted focus to combating COVID-19, showcasing a level of responsiveness that demonstrates not only the value of mesenchymal stem cell therapeutics, but their fortitude and dedication. They have not stopped. Our Foundation strives to meet the needs of our COVID-19 patients and the community by designing trials that can solve for unmet needs. ‘Long haulers’ are suffering with no solutions. We believe that using one’s own mesenchymal stem cells may provide various benefits to this patient population.”

Authorization comes as HBSCRF sets to close out two successful COVID-19 prevention studies launched in March of 2020, one of which focused on first responders and frontline healthcare workers. Since that time HBSCRF has administered more than 68 billion stem cells to fight COVID-19, completing more than 500 treatments for 165 program participants, at no cost to patients.

“The Post-COVID-19 Syndrome study is quite an achievement,” explains Registered Pharmacist and HBSCRF Clinical Research Associate Linette Rehkopf. “We were writing this protocol as circumstances were unfolding, before there was even a clear definition of the condition. This is real-time work, and it speaks to the broader capabilities of the HBSCRF team in developing and executing studies to the highest standard and with the utmost concern for our patients at every step. The heart behind everything we do is to help those who have no hope in conventional treatments. That makes our jobs more than just ‘work.’”

A green light on the “long haulers” study is not the only good news for HBSCRF. Within the last ten days, HBSCRF also gained FDA authorization to execute Primary Lateral Sclerosis (PLS) and Parkinson’s Expanded Access protocols. Updates spread rapidly among the fourteen-member HBSCRF office.

“This is a team effort,” says Clinical Research Associate Yasmany Gutierrez, gesturing to people clapping and congratulating each other in the lab. “Designing and executing a study requires physicians, nurses, pharmacists, statisticians, support personnel, all of it for the benefit of someone who needs HBSCRF. We are a team, with the patient and their family.”

At the beginning of 2021, HBSCRF carried authorization for five clinical trials, including three for COVID-19 studies, one for Alzheimer’s disease, and one for traumatic brain injury (TBI); and six Expanded Access protocol authorizations, including for amyotrophic lateral sclerosis (ALS), severe osteoarthritis, Parkinson’s disease, spinal cord injury, Cerebral Palsy, and chronic pain. With the announced authorizations for studies in Post-COVID-19 Syndrome, PLS, and the second Parkinson’s protocol, HBSCRF now carries authorization for five clinical trials and nine Expanded Access protocols.

HBSCRF, headquartered in Sugar Land, Texas, exists to revolutionize medicine by accelerating translational research in regenerative medicine to develop cures for all. HBSCRF is administered through the Greater Houston Community Foundation (GHCF). As one of the leading philanthropic grant makers, GHCF is proud to partner with donors to create a meaningful and long-lasting impact in our community. Learn more at hopebio.org.