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news.Stemedica Cell Technologies has completed 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.
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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.
Phase I of this trial was a dose-escalation study evaluating three doses of stem cells, with five subjects per dose receiving itMBMC based on weight: 0.5, 1.0 and 1.5 million mesenchymal cells per kilogram body weight. At the completion of the treatment of each dose cohort, a safety review was conducted by a Data Safety Monitoring Board (DSMB) prior to treatment at the next dose level.
Fifteen patients were treated in Phase I of this study and the DSMB unanimously recommended continuing the study into Phase IIa. An additional 21 patients were treated at a dose of 1.5 million cells per kilogram body weight.
Of the 36 patients treated in this study, 14 patients have already completed a 12 month follow-up. Only one mild adverse event was attributed to the investigational product. There were no serious adverse events or deaths in the study attributed to the product. No clinically-significant changes in laboratory or imaging results were reported.
Although the cells are allogeneic (not the patient’s own cells but from a healthy donor), the laboratory findings did not indicate an immune response and no immunosuppressive drugs were used in the clinical study.
The majority of patients experienced improvement of their conditions in comparison to the baselines as assessed by the NIHSS, MSE, BI and GDS scales.
Stemedica chief regulatory and clinical development officer Lev Verkh said: "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.
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. Stemedica is planning to present its stroke data to the FDA for a fast-track designation."
Stemedica president and chief medical officer Nikolai Tankovich said: "Stem cells have the potential to be a valuable addition to current stroke treatments.
"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."