Adult stem cells for stroke treatment may soon be tested in humans: Stemedica

Stemedica Cell Technologies, Inc may soon start clinical studies to evaluate the efficacy and safety of adult stem cells in treating stroke.

Stemedica has already filed an Investigative New Drug (IND) application with the US Food and Drug Administration for a clinical trial.

Stemedica’s trial will assess the safety, tolerability and efficacy of Stemedica’s high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

The phase I/II dose escalation and safety clinical trial,which is proposed to take place at medical centres within the United States, use allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.

The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living.

“Stemedica achieved another milestone in its development programme by moving from research to patient bedside to help people suffering from stroke,” said Nikolai Tankovich, MD, PhD, Stemedica’s president and chief medical officer.

In addition to the official licensing of Stemedica’s manufacturing facility in San Diego, California, the company has now established our own clinical trial pathway in compliance with FDA and FDB regulatory requirements. Stemedica’s goal is to receive regulatory approval of our mesenchymal stem cells for this clinical indication.

Stemedica was granted its license by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009.

The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

In February, Stem Cell Therapeutics Corp received final approval to begin patient studies using its new stem cell therapy NTx-265 for ischemic stroke.

96 patients have been enrolled to-date in Stem Cell Therapeutics’ modified REGENESIS Phase IIb acute ischemic stroke study.

Stem Cell Therapeutics expects Phase IIb patient enrollment to be complete by the end of Q1 2010 and for top-line data to be available after the 90-day patient assessment review period is complete, approximately by the end of Q2 2010.

On May 21, 2009 Stem Cell Therapeutics announced encouraging results from the original 7 patients enrolled in the trial prior to the clinical hold. The results of the Phase IIb trial from the 7 patients indicated an improvement in the treated group as compared to the placebo group.

Of the 7 patients enrolled, 5 received placebo and 2 were treated with NTx-265. A decrease in the NIHSS score represents an improvement in a patient’s functionality. A change of 4 units in the NIHSS scale is considered clinically significant.

Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company manufacturing adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials.