First US clinical study (ClinicalTrials.gov) approved to investigate plant-derived cannabinoid supplements in recovery from brain injury.
DENVER, CO, February 19, 2019 /24-7PressRelease/ — The Flowering HOPE Foundation (Boulder, CO) together with Clover Leaf University (Denver, CO) have just announced sponsorship and collaboration on the first US clinical study to be approved to investigate plant-derived cannabinoid supplements in recovery from brain injury.
The study will analyze quantitative EEG brain activity and a cannabinoid-sensitive salivary biomarker in 40 subjects with mild traumatic brain injury and controls who currently take hemp-derived botanical supplements on a regular basis (i.e. phytocannabinoids). The study is recruiting adults age 18 to 55 to participate in the year-long trial.
Jason Cranford, Founder of the Flowering HOPE Foundation (FHF), a Colorado registered 501(c)(3) nonprofit organization that supports the medicinal use of plant-derived cannabinoids, called phytocannabinoids, described the motivation for sponsoring the study:
“We hope to provide scientific support for the benefits of the natural plant-based compounds contained in hemp and move a step closer towards the unrestricted availability of non synthetic cannabinoid therapeutics.”
Cranford is a pioneer in the emerging cannabis industry with more than 25 years experience in cultivation, extraction and formulations. His know-how allowed him to breed a unique hemp strain selected for a blend of phytoterpenes and phytocannabinoids designed to alleviate treatment-resistant epilepsy in children without psychoactive side effects. The resulting strain, called Haleigh’s Hope, was formulated into a supplement offered by the FHF (2013).
The FHF has partnered with Clover Leaf University (CLU) to study brain injury. The President and Founder, Chloe Villano, received accredited approval for CLU in 2013 by the Colorado Department of Higher Education’s Private Occupational School Board. Villano is a pioneer in the cannabis and hemp industry and prioritized brain injury for the study.
“This historic study is the first of its kind and it is a privilege to work with the Flowering HOPE Foundation to address the problem of brain injury and collaborate with a neuroscientist who understands the brain endocannabinoid system, such as Dr. Cooper. There are currently no effective treatments for traumatic brain injury or chronic traumatic encephalopathy, but phytocannabinoids may be a good candidate, based on the established science of anti-inflammatory and neuroprotective mechanisms. Clover Leaf University is excited to take the lead in clinical studies that will improve and save lives,” said Villano.
The lead neuroscientist responsible for the study, Don Cooper Ph.D. is President of Real-Time Diagnostics Ventures Inc. He has published 45 peer reviewed papers on neuronal memory formation/plasticity and has studied brain cannabinoids since 2000, when he received his first NIH grant.
“I never thought it would take almost 20 years from when I started working on the brain cannabinoid system to have the first approved clinical study on phytocannabinoids and brain injury. We have convincing preclinical data showing that phytocannabinoids are neuroprotective and may be critically important for restoring neuronal function after brain injury,” stated Cooper.
For more information contact the study Clinical Coordinator at [email protected].
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