Stemedica Initiating Phase IIb/III Clinical Trial for Patients with Chronic Ischemic Stroke
19 Jan 2023
Clinical StudyCell Therapy
SAN DIEGO--(BUSINESS WIRE)-- Stemedica Cell Technologies, a best-in-class manufacturer of ischemic tolerant, allogeneic mesenchymal stem cells (itMSC), announced today that it has initiated its “PHASE IIB/III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF A SINGLE INTRAVENOUS INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS TO SUBJECTS WITH ISCHEMIC STROKE” under an existing US IND using its itMSC product.
Stemedica plans to initiate a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of a single intravenous injection of allogeneic mesenchymal stem cells to subjects with ischemic stroke. The primary objective of this study is to evaluate the efficacy of an IV injection of itMSCs for improvement in clinical outcomes of the upper-extremity portion of the body as measured on the Fugal-Meyer Scale in subjects with ischemic stroke at Day 0 through Month 6.
Secondary endpoints of the study include measuring change from the baseline in the modified Rankin Scale and Barthel Index, as well as the safety and tolerability of Stemedica’s itMSCs. Approximately 300 subjects will be enrolled in the Study, where they will be randomized into two cohorts; one receiving an IV injection of Stemedica’s itMSCs at Day 0 and standard treatment and the other cohort receiving placebo and standard treatment.
Stemedica successfully completed a Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke in patients with chronic ischemic stroke and demonstrated an excellent safety pro itMSCs. Statistically significant improvements were observed in study participants in four efficacy endpoints: NIH Stroke Scale (NIHSS) for neurological assessment, Barthel Index (BI) for ability to perform daily tasks, Mini-Mental Status Exam (MMSE) for mental status, and Geriatric Depression Scale (GDS) for degree of depression. The study was conducted at three centers: University of California, San Diego (UCSD); Mercy Gilbert Medical Center; Gilbert, Arizona; and University of California, Irvine (UCI).
“It is critical to address the enormous medical and social issues caused by approximately ten million new cases of stroke each year around the world. We are encouraged that Stemedica’s Phase IIb/III clinical trial under the FDA IND can validate the role that our ischemic tolerant mesenchymal stem cells can play in addressing this crisis,” said Dr. Nikolai Tankovich, Stemedica’s President and Chief Medical Officer. “Stemedica has begun discussions with possible Strategic Partners that have a deep commitment to advancing treatment solutions for stroke and see Stemedica’s study design and product uniqueness as a keen strategic advantage in today’s marketplace.”
“To date, there are no effective drugs or therapies available for the treatment of chronic ischemic stroke with current treatments primarily relying on rehabilitation to prevent further degradation. We hope to bring this medication to patients with this debilitating condition,” said Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer. “Unlike other stroke trials using stem cells, this is the first clinical trial of its kind, evaluating Stemedica’s itMSCs. We believe the unique nature of our low oxygen-manufactured cells will yield favorable cell proliferation, gene expression, cytokine production, and effective cell migration as part of positive patient responses to treatment using Stemedica’s itMSCs.”
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for COVID-19 and Alzheimer’s Disease. Stemedica’s cells 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.
About Stroke
Stroke is among the leading causes of death and disability in adults. In 2019, over 10 million new cases were reported globally, and over 6 million died due to stroke. Ischemic stroke incidents comprise nearly 90% of all strokes. The mean survival post stroke is 6 to 7 years with more than 85% of patients living past the first year post stroke, enduring years of disability and neuropsychiatric syndrome. Once entering the chronic stage of stroke, the patient’s welfare is affected, and significant family and societal burdens are experienced. To date, there are no effective drugs or therapies available for the treatment of chronic stroke; therefore, medical and social experts believe it is vitally important to identify new approaches in treating those afflicted by ischemic stroke.
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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