University of California Irvine (UCI) Doses First Patient in Phase IIa Clinical Trial Using Stemedica's Stem Cells for Alzheimer's disease
IRVINE, Calif., Nov. 1, 2016 /PRNewswire/ -- Stemedica International, SA, a Stemedica Cell Technologies Inc. subsidiary that uses its proprietary allogeneic stem-cell therapies for Alzheimer's disease, announces enrollment of its first patient at the University of California, Irvine (UCI). The study, is entitled "A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer's disease (STEM4AD™)."
The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer's disease (AD) at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's criteria.
"Our primary objective for this clinical trial is the evaluation of safety and tolerability of itMSCs in subjects with mild to moderate dementia due to Alzheimer's disease," said Lev Verkh, Ph.D. Stemedica's Chief Regulatory & Clinical Development Officer. He continued "We will also compare treatment and placebo groups for a preliminary efficacy assessment by neurologic, functional, and psychiatric endpoints."
Stemedica's bone marrow-derived, allogeneic ischemic-tolerant mesenchymal stem cells (itMSCs) are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing.
"The Hospital of the University of California, Irvine has one of the nation's most advanced facilities, and has tremendous resources and expertise that contribute to the validity of our study results," says Nikolai Tankovich, M.D., Ph.D., Stemedica International's Executive Chairman. "We hope our unique, hypoxically-grown stem cells will halt or slow down the progression of Alzheimer's disease and other forms of dementia."
More information about this important clinical trial including enrollment details, can be found at https://clinicaltrials.gov/ct2/show/NCT02833792?term=stemedica&rank=1.
About Stemedica International S.A.
Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer's disease. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute its parent company's allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer's disease. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies' cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit www.stemedica-intl.com.
About Stemedica Cell Technologies Inc.Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, Alzheimer's disease and traumatic brain injury. Stemedica's products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California, and can be found online at www.stemedica.com.
Forward Looking Statements
This press release may contain forward-looking statements. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
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SOURCE Stemedica International