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Stemedica Reports Positive Results from Phase IIa Clinical Trial Using IV Administration of Mesenchymal Stem Cells for Ischemic Stroke

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Stemedica Reports Positive Results from Phase IIa Clinical Trial Using IV Administration of Mesenchymal Stem Cells for Ischemic Stroke

San Francisco, CA – CONGRESS OF NEUROLOGICAL SURGEONS October 19, 2019 – October 23, 2019 – Study sponsor Stemedica a global biotechnology company that uses cGMP manufactured, ischemia-tolerant (itMSCs), bone marrow derived, allogeneic mesenchymal stem cells for ischemic conditions, presented data from its clinical trial “A Phase I/II, 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” at the 2019 Congress of Neurological Surgeons (CNS). Michael Levy MD, PhD, FACS, FAANS, the study’s principal investigator as well as Professor of Neurosurgery at the University of California, San Diego (UCSD), presented the study results at the Cerebrovascular Section Meeting illustrating the safety of intravenous administration of Stemedica stem cells and statistically significant improvement in efficacy parameters in patients with chronic ischemic stroke relative to the baseline measurements over a 12 month follow up period. This represents the first clinical trial to study the effects of intravenous (IV) administration of ischemia-tolerant mesenchymal stem cells in patients with ischemic stroke.

“Intravenous transfusion of low oxygen mesenchymal bone marrow cells in patients with disabling chronic stroke was safe and significantly improved several behavioral measures. These data support proceeding to a randomized, placebo-controlled, multicenter study,” said Dr. Levy.
Results Validate Safety and Potential Benefits of IV itMSC Administration
Study: The target population included patients with chronic ischemic stroke and substantial functional deficits; a group for whom treatment options remained limited. The primary outcome of the study was safety, based on serial measures of behavior, CT scans, and laboratory testing. Four secondary endpoints were scored serially to derive estimates of behavioral changes relatively to the baseline over a period of 12 months: 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: UCSD; Mercy Gilbert Medical Center, Gilbert, Arizona; and University of California, Irvine (UCI).
Entry criteria included ischemic stroke >6 months prior to administration, substantial functional deficits (subject confined to a wheelchair, had home-nursing care, or needed assistance with activities of daily living), no substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment in the study per medical history, and NIHSS score=6-20.
Enrollees received a single intravenous dose of allogeneic mesenchymal bone marrow cells. Phase I used a dose escalation design (3 tiers, n=5 each). Phase IIa (n=21) was an expanded safety cohort. The primary endpoint was safety over 1-year. Secondary endpoints examined behavior, with a pre-specified focus at 6-months.
Subject status at enrollment prior to treatment: At baseline, subjects (n=36) averaged 4.2±4.6 years post-stroke, age 61.1±10.8 years, NIHSS score 8 [6.5-10], and Barthel Index 65±29.
Safety: Study testing disclosed no safety concerns. No subject showed a positive reaction to intradermal testing. In Phase I, each dose (0.5, 1.0, and 1.5 million cells/kg body weight) was found safe, as a result Phase IIa subjects received 1.5 million cells/kg. Two subjects were lost to follow-up, one was withdrawn, and two died (unrelated to study treatment). There were 15 serious adverse events, none possibly or probably related to study treatment. Two mild adverse events were possibly related to study treatment, a urinary tract infection and IV site irritation. Treatment was determined to be safe based on serial exams, EKGs, laboratory tests, and pan-CT scans.
Behavioral Effects: Improvements across all subjects post-transfusion and for all four secondary endpoints were achieved. Improvements in each index were: Barthel Index (6.8±11.4 points, p=0.002); in NIHSS (-1.25±1.7 points, p<0.001); Mini Mental Status Exam (1.8±2.8 points, p<0.001); and Geriatric Depression Scale (-1.6±3.8 points, p=0.015). At baseline 11.4% (4/35 subjects) had Barthel Index=95-100 (favorable outcome); at 6-months, 27.3% (9/33); by 12-months, 35.5% (11/31).

Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer of Stemedica added, “Stroke is the third most common cause of death in most western populations after coronary-heart disease and cancer. Stroke is a life-threatening and life-debilitating neurological disorder resulting in tremendous burden on patients, their families, and society. We are encouraged with the results of this study showing safety and preliminary efficacy of itMSCs in patients with chronic ischemic stroke.”

Results from a study sponsored by Stemedica a global biotechnology company that uses allogeneic stem cells for ischemic conditions, form the basis for a peer-reviewed paper published in Stroke entitled “Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke.” Co-authors include Michael L. Levy, MD, PhD, John R. Crawford, MD, Nabil Dib, MD, Lev Verkh, PhD, Nikolai Tankovich, MD, PhD and Steven C. Cramer, MD.

About Stemedica

Stemedica 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 ischemic stroke, and Alzheimer’s Disease. Stemedica’s cell 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 stem cells 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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