Stemedica Cell Technologies has reported positive results from its Phase I/IIa clinical trial evaluating the safety, tolerability, and preliminary efficacy of ischemic tolerant mesenchymal stem cells (itMSCs) to treat ischemic stroke.
itMSCs is an allogeneic progenitor cell therapy currently being studied for the treatment of ischemic stroke and Alzheimer’s disease.
The results showed that intravenous administration of itMSCs was safe and well tolerated among the enrolled subjects.
No serious adverse events or clinically significant changes in lab and imaging measurements were observed.
Stemedica Cell Technologies president and chief medical officer Nikolai Tankovich said: “The positive results of this clinical trial give Stemedica important insight into how our hypoxia-induced cGMP-manufactured itMSCs perform within an ischemic environment of stroke brain tissue as it relates to safety and potential efficacy.
“These results are also interesting in light of the fact that patients enrolled in the study had a minimum post-stroke time of six months at baseline with some patients having suffered a stroke more than 20 years prior to treatment.”
Stemedica examined a single intravenous dose of itMSCs as part of the Phase I/IIa study.
The first part of the multi-centre, open-label, two-part trial enrolled 15 patients who received intravenously one dose of 0.5 million, one million or 1.5 million cells per kilogram of itMSCs.
Part two of the trial saw 21 subjects treated with 1.5 million cells per kilogram of itMSCs.
The trial’s primary endpoint was the safety of itMSCs over 12 months as assessed by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations and others.