Neueralstem finally has its SCI trial on track. The company got FDA clearance
a year ago January to implant spinal cord-derived stem cells into people a year to two years post spinal cord injury. It’s a safety trial, starting at the University of California, San Diego.
The company has used the same cell line since 2010 in patients with ALS. The cells have been safely implanted in about two dozen people.
The SCI trial is listed on ClinicalTrials.gov
as "by invitation." Phone number is below.
From the trial notice:
The primary objective of the study is to determine the safety of human spinal stem cell transplantation for the treatment of paralysis and related symptoms due to chronic spinal cord injury (SCI) [ Time Frame: The primary outcome measure will be assessed over a 60 month period. ] [ D
The secondary objective of the study is to evaluate the graft survival in the transplant site by MRI. [Time Frame: An MRI will be performed at Visits 5, 10, 16, 19 and 24.]
The secondary outcome measures of the study is to evaluate the ability of HSSC transplantation to positively affect AIS level ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG).
Here’s the press release from the company:
Neuralstem, Inc. 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. The trial, which already has FDA approval, and has a one-year completion goal, will be under the direction of principal investigator (PI) Joseph Ciacci, MD, UC San Diego School of Medicine and neurosurgeon at UC San Diego Health System. Much of the pre-clinical work with the NSI-566 cells in spinal cord injury was conducted at UC San Diego School of Medicine by Martin Marsala, MD, professor in the Department of Anesthesiology, who will be another study investigator.
"Moving our spinal cord cells into human trials for a second indication in the U.S. is a major step forward for the company," said Karl Johe PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer. "We have demonstrated that the surgical route of administration is safe and robust; that the cells survive transplantation and are biologically active in the patients, and that both the cells and the surgery are well-tolerated and safe. In animals, we have shown compelling proof-of-principle of return of significant function. With 30 successful spinal surgeries completed in our ALS trials, we feel we are ready to tackle spinal cord injury and are excited to begin this ground-breaking study. We wish to thank and acknowledge the support of our collaborators at UCSD, without whom this trial would not be possible."
In a peer-reviewed study, published in the journal, STEM CELL RESEARCH AND THERAPY, in May, 2013, rats transplanted with NSI-566 stem cells three days after a spinal cord injury at L3 (lumbar 3), showed improvement along several measures of motor function and a reduction of spasticity. The study demonstrated that intraspinal grafting of NSI-566 cells during the acute phase of a spinal cord injury could represent a safe and effective treatment that ameliorates post-injury motor and sensory deficits.
In a separate peer-reviewed study, published in the journal, CELL, in August, 2012, rats with surgically transected spinal cords transplanted with Neuralstem's NSI-566 stem cells, recovered significant locomotor function, regaining movement in all lower extremity joints. Furthermore, the cells turned into neurons which grew a "remarkable" number of axons that extended for "very long distances," bridging above and below the point of severance. These neurons also appeared to make reciprocal synaptic connectivity with the host rat spinal cord neurons in the gray matter for several segments below the injury.
Patients wishing to find out about the trial should contact the principal investigator's office: 619-471-0798.