Creative Medical Technology Holdings, Inc. issued the following announcement on July 9.
(OTC-CELZ) Creative Medical Technology Holdings announced today completion of preclinical studies assessing the anti-inflammatory and neuroregenerative activities of AmnioStem™. These studies complete what the Company believes is necessary for filing an Investigational New Drug (IND) application with the FDA to initiate clinical trials in patients with stroke.
The studies, which were conducted by Company scientists and collaborators demonstrated that AmnioStem™ amniotic fluid stem cells are potent suppressors of brain inflammation from cells called microglial cells. It is believed that microglial cells contribute to the death of brain tissue subsequent to stroke. The data provides a mechanistic explanation for the ability of AmnioStem™ cells to suppress stroke associated pathology in animal models.
"After extensive laboratory and animal studies, we are pleased to be in the position to conclude our preclinical experimentation and initiate the process of submitting our work to the FDA for permission to enter human studies." Said Thomas E Ichim, Ph.D, Chief Scientific Officer of the Company. "Our findings demonstrate that AmnioStem™ is superior to other stem cell types both in suppressing inflammation and stimulating regeneration of injured brain tissue. In contrast to other treatments that have been tried unsuccessfully for stroke, we believe that AmnioStem™ will be superior because it is the youngest available type of adult stem cell to be utilized for this indication."
Amniotic stem cells are considered to be younger than other types of cells because they provide support for the developing fetus while it is floating in the amniotic fluid. It is believed that the ability of the fetus to heal without scars is due in part to the high concentration of stem cells in the amniotic fluid. The current data generated by the Company shows that amniotic stem cells reprogram immune cells like microglia cells to stop inflammation and to trigger the stem cells that already exist in the brain to start multiplying and initiate the repair processes.
"Our work on the AmnioStem™ program is supported by key opinion leaders in the field such as Dr. Santosh Kesari, MD, Ph.D, Director of Neuro-Oncology, Providence Saint John's Health Center, who leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute. Dr. Kesari is Chief Medical Advisor for AmnioStem LLC, which is the CELZ subsidiary developing AmnioStem™[1]." Said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "We are eager to work with our clinical colleagues and with the FDA in order to provide a new treatment to the devastating consequences caused by stroke."
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visit: www.creativemedicaltechnology.com.
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