Articles Tagged: Clinical Trial
September 15, 2014 | Category: News
The University of Arizona Medical Center is the site of a two-year clinical trial for a drug that could help people with acute spinal-cord injuries.
Sixty trauma centers in the U.S., Canada and Europe will test the safety and efficacy of the investigational drug SUN13837, to determine whether it can protect and regenerate spinal nerves, UA Medical Center officials say.
The study is sponsored by Asubio Pharmaceuticals, Inc. Patients will be randomly assigned to receive either a placebo or SUN13837 within 12 hours of injury and then daily for 28 days. Continue Reading »
August 25, 2014 | Category: News
Only hours after a traumatic spinal cord injury, when the life-and-death moments have passed and ongoing challenges are just coming into focus, some patients are receiving an experimental drug that may change their lives.
The investigational medication, called SUN13837, is given intravenously within 12 hours of a traumatic spinal cord injury (SCI) and then daily for 28 days. It is a fat-soluble molecule that may protect damaged neurons and even promote new nerve growth, preventing some loss of function. Continue Reading »
June 23, 2014 | Category: News
An array of techniques – some available now and others on the horizon – aim to restore movement and other functions in patients with spinal cord injuries.
A paraplegic wearing an Iron Man-like exoskeleton took the first kick of the World Cup soccer tournament during the opening ceremony in Sao Paulo, Brazil, a testament to recent advances in treating spinal cord injuries.
The robotic bodysuit took cues from the user’s brain activity to power his steps forward. It was developed by Brazilian doctor Miguel Nicolelis, who is on the faculty at Duke University, and more than 150 scientists from around the world. Continue Reading »
While human embryonic stem cells (hESCs) were originally created in 1998, it wasn’t until 2009 — over a decade later — that they were approved by the FDA for use in a clinical trial in people. It was a long wait, but the trial was quite the promising one. The clinical trial, undertaken by the Geron Corporation, was for using hESCs to treat patients with spinal cord injuries and paralysis.
Very unfortunately, the trial became stalled in late 2011, mostly due to financial concerns (but it did undoubtedly help pave the way for other hESC-based clinical trials to get FDA approval starting in 2010). Continue Reading »
April 28, 2014 | Category: News
Scaffold Designed to Facilitate Neural Growth in Spinal Cord Injury
CAMBRIDGE, Mass.–(BUSINESS WIRE)–April 28, 2014– InVivo Therapeutics Holdings Corp. (NVIV) announced today that it has begun shipment of its innovative investigational device, a degradable polymer Neuro-Spinal Scaffold for spinal cord injury (SCI) patients, for initiation of the company’s first clinical trial. InVivo has pioneered a new treatment platform utilizing a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic SCI. In preclinical studies, the Neuro-Spinal Scaffold promoted cell adhesion, neurite sprouting, the growth of remodeled spinal cord tissue containing myelinated axons, and improved motor function. Continue Reading »
April 18, 2014 | Category: News
| Spinal Cord Injury: T-1
Neuralstem, announced that the Institutional Review Board of the University of California, San Diego, School of Medicine has approved the phase I safety trial to treat chronic spinal cord injury (cSCI) with its NSI-566 stem cells. The NSI-566/cSCI phase I trial will enroll patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association (AIS) A level of impairment, between one and two years after injury. AIS A impairment, which is complete paralysis, refers to a patient with no motor or sensory function in the relevant segments at and below the injury. Continue Reading »
April 15, 2014 | Category: News
“Chondroitinase improves the outcome after spinal cord injuries in lab animals; therefore it could also benefit dogs and people suffering from the same conditions.”
The purpose of our clinical trial is to help these severely affected dogs by testing if a new treatment, called chondroitinase, may improve the outcome after spinal cord injury in dogs.
“Spinal cord injuries can lead to serious consequences including the impairment of movement, sensation and urination; this is because spinal cord tissue does not regenerate effectively” Continue Reading »
Rutgers’ Wise Young and Army Capt. Boyd Melson fight to bring clinical trials to the United States
What would one of the world’s leading researchers in spinal cord injury and a professional boxer have in common? Under normal circumstances not much.
But Wise Young, a Rutgers neuroscience professor who is searching for a cure for spinal cord injury, and Boyd Melson, a West Point graduate and Army captain who is dedicating his life and boxing prize money to help make this dream happen, are two men on the same mission. Continue Reading »
October 2, 2013 | Category: News
NEWARK, Calif., Oct. 2, 2013 (GLOBE NEWSWIRE) — StemCells, Inc. (Nasdaq:STEM) announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application for clinical testing of the Company’s proprietary HuCNS-SC® human neural stem cells as a treatment for spinal cord injury. As a first action under this IND, the Company is working to open U.S. sites for its Phase I/II clinical trial for chronic spinal cord injury, which is currently underway in Switzerland and Canada. Continue Reading »
September 25, 2013 | Category: News
AC105 improved motor function after spinal cord injury in preclinical studies
ARDSLEY, N.Y.–(BUSINESS WIRE)–Sep. 25, 2013– Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the first patient has been enrolled in a trial of AC105, its proprietary magnesium formulation for the treatment of spinal cord injury (SCI). This Phase 2 trial will evaluate the safety and tolerability of the drug in people with traumatic SCI, and also incorporates several exploratory efficacy measures. Continue Reading »