Stemedica Cell Technologies Announces Completion of Enrollment in Phase I/IIA Clinical Trial for Ischemic Stroke
San Diego, California, January 27, 2016: Stemedica announced completion of enrollment into “A Phase I/IIa, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.” This study focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have home nursing care or assistance with the general activities of daily living). In addition, inclusion criteria specified that patients have no substantial improvement in neurologic or functional deficits for the two months prior to enrollment in the study.
The primary goal of this study is to evaluate the safety and tolerability of Stemedica’s ischemia-tolerant allogeneic mesenchymal bone marrow cells (itMBMC) administered intravenously. Patient status is assessed at specified time points over a period of 12 months using the following assessment scales: National Institutes of Health Stroke Scale (NIHSS), Mini Mental Status Exam (MMSE), Barthel Index (BI) and The Geriatric Depression Scale (GDS). This study was conducted at three clinical sites: the University of California, San Diego; Mercy Gilbert Medical Center, Arizona; and University of California, Irvine.
“These findings represent a significant milestone in the clinical development of
Stemedica’s ischemia-tolerant allogeneic mesenchymal bone marrow cells for the treatment of the chronic phase of stroke,” said Lev Verkh, Ph.D., Chief Regulatory and Clinical Development Officer of Stemedica. He continued, “We observe the same clean safety profile of our product in other ongoing clinical trials in patients with chronic heart failure and in patients with photoaged skin. Stemedicais planning to present its stroke data to the FDA for a fast-track designation.”
“Stem cells have the potential to be a valuable addition to current stroke treatments,” said Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica. “We are happy with the continued progress of Stemedica’s Phase I/IIa ischemic stroke trial and are making plans for a Phase IIb study.”
About Stemedica
Stemedica 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 and Alzheimer’s disease. 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.
This press release may contain forward-looking statements regarding the business strategy of Stemedica and its subsidiaries (“Stemedica”), including statements regarding Stemedica’s future clinical studies and planned regulatory activities. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity or performance to differ materially from those expressed or implied by 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.