Transplanted neural stem cells (NSCs) developed by Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development were successful in treating rats with spinal cord injury (SCI). The research conducted by Ivan Cheng, M.D., Assistant Professor in the Department of Orthopedic Surgery, Stanford University School of Medicine, was presented at the North American Spine Society Annual Meeting in Chicago, IL on November 2, 2011. Dr. Cheng’s paper was entitled Functional Assessment of Acute Local Versus Distal Transplantation of Human Neural Stem Cells Following Spinal Cord Injury. The data represent a significant finding in the field of spinal cord research.
Twenty-four subjects underwent a controlled injury at the T10 (thoracic) level, rendering them paraplegic. Experimental subjects received either an injection of Stemedica’s ischemic tolerant human NSCs adjacent to the site of injury (local injection), or an intrathecal injection (lumbar puncture) of NSCs distal to the site of injury. Control subjects received an injection of control media alone either local or distal to the site of injury. Subjects were assessed following injury and then weekly for six weeks.
According to Dr. Cheng, “The acute transplantation of NSCs into the rat’s injured spinal cord lead to significant functional recovery. This occurred whether the cells were injected either locally or distally. This preclinical research holds promise for patients in that we may be able to inject Stemedica NSCs through a traditional lumbar puncture in the acute phase after their injury.”
Stemedica’s ischemic tolerant neural stem cells were developed by Alex Kharazi, M.D., Ph.D., Chief Technology Officer at Stemedica and were made available to leading medical institutions for preclinical research. Dr. Kharazi notes that “Dr. Cheng’s data in rats support our internal research. We have successfully transplanted NCSs into chicken embryonic brain and demonstrated that our NSCs engraft, migrate and differentiate into a variety of neural and glial cells.”
An Investigational New Drug (IND) application for NSC use in human clinical trials is currently being prepared for submission to the Food and Drug Administration for initiation of clinical trials in Q1, 2012. The NSCs are the second product to be released by the San Diego based company. Ischemic tolerant mesenchymal stem cells are currently in a Phase I/IIa clinical trial for ischemic stroke at the University of California, San Diego School of Medicine.
Nikolai Tankovich, M.D., Ph.D., Stemedica’s President and Chief Medical Officer, points to the significance of these findings, “This basic science research is encouraging for the more than 250,000 Americans who suffer from spinal cord injury, and the 11,000 who join their ranks each year. We look forward to the day when effective treatment for spinal cord injury can limit and help reverse the damage and suffering that these patients endure.”
Maynard Howe, Ph.D., CEO of Stemedica noted that, “We anticipate continuing our collaboration with the researchers at Stanford University to advance a clinical trial path for patients with this debilitating condition.”
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.
(Source: November 14 2011; Stemedica Cell Technologies, Inc.)