TIJUANA, Mexico, Dec. 24, 2014 /PRNewswire/ -- Novastem, a leader in regenerative medicine, announces the treatment of its first patient in its study for ischemic stroke at Clinica Santa Clarita. According to the American Stroke Association, ischemic strokes account for 87 percent of all stroke cases. Novastem continues to enroll qualified patients in the study, entitled "Internal Research Protocol in Combination Therapy of Intravenous Administration of Allogeneic Mesenchymal Stem Cells and Intrathecal Administration of Neural Stem Cells in Patients with Motor Aphasia due to Ischemic Stroke." All participants receive a unique, combination therapy using a method covered by a United States patent owned by Stemedica Cell Technologies for the therapeutic use of its allogeneic, ischemia-tolerant mesenchymal and neural stem cells.
Study sponsor Novastem is the only company licensed to use Stemedica's stem cell products for studies in Mexico. Novastem's research is conducted at its Clinica Santa Clarita facility, which is federally licensed to use stem cell therapies. The current, Research Ethics Committee (REC) approved the study's purpose to determine if Stemedica's products achieve signs of improvement in patients with ischemic stroke. It marks the first time ischemic stroke is being treated with a patented medical method that comprises intrathecal administration of hypoxically-grown neural stem cells and intravenous administration of hypoxically-grown mesenchymal stem cells. This combinatory approach is designed to treat the after effects of ischemic strokes.
"Novastem and Clinica Santa Clarita are committed to advancing the research of neurodegenerative disease, and we are pleased to be working with internationally-recognized physician Clemente Humberto Zuniga Gil, MD as the principal investigator and study designer," says Rafael Carrillo, Novastem's President. "Our medical team believes that Stemedica's mesenchymal and neural stem cells, used in this unique combination therapy, will restore and build new vascularization, improve the blood supply, reconnect damaged neural networks and improve functionality of areas affected by our patients' ischemic stroke."
About the Ischemic Stroke Clinical Trial
This study aims to evaluate functional changes on subjects after the administration of mesenchymal and neural stem cells. The protocol is approved by the Research Ethics Committee of Clinica Santa Clarita, which is federally registered and licensed by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), a division of Mexico's Ministry of Health. Patients receive intrathecal administration of neural stem cells and intravenous administration of mesenchymal stem cells. Progress is tracked at the baseline, at 90 days and at 180 days, and it is measured using the United States National Institute of Health Stroke Score (NIHSS), Stroke and Aphasia Quality of Life Scale-39 (SAQCOL-39) and the Boston Diagnostic Aphasia Examination (BDAE) neuropsychological evaluation for diagnosis. In addition, an MRI taken with a gadolinium-based contrast agent (GBCA) is performed as a baseline analysis and at the study's conclusion. The endpoint is to evaluate the safety and tolerance of the two-cell treatment, as well as observing initial changes in functionality.
About Novastem's Ischemic Stroke Therapy
Novastem's ischemic stroke therapies feature Stemedica's ischemia-tolerant mesenchymal stem cells (itMSCs) in combination with ischemia-tolerant neural stem cells (itNSCs). Stemedica's allogeneic itMSCs and itNSCs are unique because they are manufactured using proprietary technology. In vitro and in vivo experiments demonstrate that cells exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to other MSCs and NSCs, Stemedica's stem cells secrete higher levels of growth factors and other important proteins associated with angiogenesis and healing.
Novastem is a research organization focused on developing effective stem cell treatment protocols and has ongoing Research Ethics Committee approved clinical trials using cell products manufactured by Stemedica Cell Technologies. These indications include ischemic stroke, ischemic heart failure, osteoarthritis and several neurodegenerative diseases. For more information, please visit www.novastem.mx.
About Clinica Santa Clarita
Clinica Santa Clarita is a research and specialized medical service center located in Tijuana, Mexico. The facility is located 20 minutes from downtown San Diego. The facility allows for enrollment of patients from both Mexico and the United States. Clinica Santa Clarita is federally licensed to import, bank, and administer stem cell therapy. Learn more about us at www.clinicasantaclarita.com.
About Stemedica Cell Technologies Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that manufactures best-in-class, allogeneic, adult stem cells and stem cell-derived factors. The company has a cGMP compliant facility and is government-licensed to manufacture clinical-grade stem cells currently used in United States FDA approved clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging and ischemic stroke. Stemedica's products are also used by research institutions and hospitals for pre-clinical and clinical (human) trials. Under the auspices of the FDA and other international regulatory institutions, Stemedica and its international partners are conducting clinical trials for other indications using Stemedica's manufactured adult, allogeneic stem cells. The company has headquarters in San Diego, California, and can be found online at www.stemedica.com.