Study Sponsored by Stemedica Cell Technologies, Inc.
SAN DIEGO, Sept. 30, 2019 /PRNewswire/ -- Results from a study sponsored by Stemedica Cell Technologies, Inc., 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.
As indicated in the Stroke publication, "Stroke is perennially among the leading causes of human disability and the leading neurological cause of lost disability-adjusted life years. The mean survival after stroke is 6-7 years, with more than 85% of patients living past the first-year post-stroke, many with years of enduring disability. Many restorative therapies are under study to improve outcomes after stroke." However, restorative therapies often have a short time window for improvement usually measured in days-months.
"Based on Stemedica's preclinical data that supported the safety and efficacy of its MSCs as a restorative therapy to improve outcomes after stroke, the company was granted approval by the FDA to conduct a Phase I/IIa dose escalation trial that examined the effects of a single IV infusion of Stemedica's cGMP manufactured allogeneic ischemia-tolerant MSCs," said Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer of Stemedica.
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: University of California, San Diego (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).
Conclusions: The current study is the largest trial of intravenous MSCs in patients with chronic stroke and the first to evaluate allogeneic MSC therapy in this population. It is also the first study to evaluate MSCs grown under hypoxic conditions favorable to cell proliferation, gene expression, cytokine production and migration. While patients with stroke in the chronic stage generally show significant functional decline, enrollees in the current study showed 12 months of continued functional improvements across all secondary endpoints.
Intravenous transfusion of allogeneic ischemia tolerant MSCs in patients with chronic stroke and substantial functional deficits was safe and suggested behavioral gains. These data support proceeding to a randomized, placebo-controlled study of this therapy in this population.
Dr. Nikolai Tankovich, President and Chief Medical Officer added, "Stemedica is encouraged by the results of the study which demonstrated safety and preliminary efficacy of its cell therapy product for the treatment of chronic ischemic stroke patients. It is a significant milestone for Stemedica to bring this new cellular medication to patients with debilitating conditions caused by a stroke. Stemedica plans to move forward to a Phase-IIb discussion with the FDA."
Michael Levy, MD, PhD, FACS, FAANS, Professor of Neurosurgery at UCSD and the Principal Investigator of this study commented: "Based on my clinical trial work in Stemedica's Ischemic Stroke trial, my experience to date with Stemedica's allogeneic ischemic tolerant mesenchymal stem cell product suggests that the product is first and foremost safe and secondarily has the potential to produce unparalleled medical benefits."
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 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 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
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