Aug 25, 2010 - It is a publicly traded biotherapeutics company. The company’s mission is to apply its patented human neural stem cell technology to treat diseases and conditions of the central nervous system (CNS). Neuralstem, Inc announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I safety trial for chronic spinal cord injury with its spinal cord stem cells.
In 2005, Hans Keirstead, a scientist at the University of California
The first clinical trial of embryonic-stem-cell therapy was approved by FDA for Geron, a small biotech company in 2009. ALS is a fatal neurodegenerative disease that causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. About 30,000 Americans have ALS at any given time, according to the ALS Association. "We are very encouraged by what we have learned transplanting the first six ALS (Amyotrophic Lateral Sclerosis) patients in our FDA-approved trial in Atlanta," said Chief Scientific Officer and Chairman of Neuralstem's Board of Directors, Karl Johe, Ph.D. Johe invented the technology that allows the company to manufacture billions of copies of stem cells that are taken from a single source of spinal cord cells: cells that were extracted from fetal tissue, which was donated to the company. The ALS Association has supported the work of Dr. Nick Boulis, the Emory neurosurgeon who developed the surgical technique used to inject the stem cells.
This multicenter Phase I safety trial will enroll a total of 16 long-term, or chronic, spinal cord injury patients, with an American Spinal Injury Association (ASIA) Grade A level of impairment, one-to-two years post-injury. ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis. The company is proposing to transplant patients with injuries in the thoracic (mid-back) regions first. Once the safety of the surgeries has been established, it plans to transplant patients whose injuries are in the cervical (upper spinal cord) region. Transplantation of Neuralstem’s human spinal stem cells is meant to provide a neuron-rich substrate to the injured segments of a patient’s spinal cord to promote further repair, regeneration, and reorganization.
The goal is to harness this inherent plasticity and promote reorganization by combining stem cell transplantation with the modern concept of activity-guided rehabilitation. Neuralstem believes that, in chronic cases, the transplants may promote reorganization of segmental circuitry over the long-term. In the cervical region of the spinal cord, this could result in improved breathing capacity and recovery of sensori-motor functions of the upper limbs. Segmental reorganization induced by, and utilizing graft-derived neurons, may also result in improved locomotion. Neurons differentiated from Neuralstem’s HSSC (human spinal stem cells) grafts in chronic thoracic injuries may serve a bridge to connect the axons located above the site of injury to neurons of segments below the injury site. HSSC grafts may also encourage axons to regenerate through the graft to segments below the injury.
Source :
0 comments:
Post a Comment