The latest news and information about what's going on with SCI science and research. Brought to you by Sam Maddox, author of the Christopher & Dana Reeve Foundation Paralysis Resource Guide.

Stem Cell Trial: Sensory Gains In 7 Of 12

It’s coming up on 10 years now since a scientific paper was published that would embolden California-based StemCells, Inc. to take an experimental line of neural stem cells into human trials. This 2005 research, conducted by Brian and Aileen Anderson, at the University of California, Irvine’s Reeve-Irvine Center, funded in part by the Reeve Foundation, was titled “Human neural stem cells differentiate and promote locomotor recovery in spinal cord-injured mice.”

When transplanted into mice, these human cells, derived from the spinal cord of an aborted fetus, survived, migrated and seemed to act like neurons. They also appeared to remyelinate damaged spinal cord axons, and what’s more, once engrafted in the spinal cord, they improved locomotor recovery of the test animals. “These data suggest that hCNS-SCns [stands for human central nervous system spinal cord neurospheres] may possess therapeutic potential for CNS injury and disease,” the paper noted.

Some therapeutic potential? Apparently so. Last week, StemCells, Inc. updated the spinal cord medical community regarding its continued clinical trials for the Reeve-Irvine cell line. More than half of those in the study got some measure of recovery.

The company began implanting its cells in spinal cord injury patients (from three to 12 months post-injury) in Zurich in 2012. They were mainly looking at safely, which was confirmed; there were no tumor or adverse side effects. There were also reports of sensory recovery beyond that of matched patients who had no treatment. The company was encouraged to expand the trial to Canada and later, in cervical spinal cord injuries, to the United States.


The latest results, says Michael Fehlings, MD, PhD, the clinician-scientist who ran the Toronto part of the trial, are “profound:”

"We have now legitimately entered into the era of regenerative neuroscience," he said. Twelve patients with thoracic spinal cord injuries were part of the study; seven had sensory gains (when tested with light touch, pin pricks or heat) beyond what would normally be expected.


Added Fehlings, “... this isn't occurring in shady overseas clinics that are selling things to vulnerable people. This is occurring under the auspices of the most rigorous federal agencies in the world. So the science is real and I feel very hopeful for the future."

Seven AIS A patients and five AIS B patients were enrolled; they ranged in age from 19 to 53. There were 11 males and one female; each got dosed with 20 million stem cells above and below the lesion area. [AIS A means no motor or sensory below lesion; B means limited sensory preservation].

From a company press release:
The international, open-label, Phase I/II trial evaluated both safety and preliminary efficacy of StemCells, Inc.'s proprietary HuCNS-SC human neural stem cells as a treatment for chronic spinal cord injury. The trial enrolled twelve patients who had suffered injury to the thoracic cord and were in the early chronic stage of recovery.
 
The analysis of the study demonstrated that the surgical transplantation technique and cell dose were safe and well tolerated by all patients. HuCNS-SC cells were injected directly into the cord both above and below the level of injury and sequential examinations of the patients over the course of twelve months showed no abnormal changes in spinal cord function associated with the transplantation technique. There were no adverse events attributed to the HuCNS-SC cells.
 
In addition to safety, analysis of the twelve-month data revealed sustained improvements in sensory function that emerged consistently around three months after transplantation and persisted until the end of the study. The patterns of sensory gains were confirmed to involve multiple sensory pathways and were observed more frequently in the patients with less severe injury; three of the seven AIS A patients and four of the five AIS B patients showed signs of positive sensory gains confirming the previously released interim results. In addition, two patients progressed during the study from the most severe classification, AIS A, to the lesser degree of injury grade, AIS B.

The results were presented last week in Montreal at a joint meeting of the International Spinal Cord Society and the American Spinal Injury Association. Dr. Armin Curt, head of the Spinal Cord Injury Centre at Balgrist University Hospital who led the Zurich team, said the results strongly suggest a biologic action of the stem cells. "Such gains are unlikely to have occurred spontaneously given the average time from injury,” he said.

StemCells, Inc. has already begun enrolling 52 patients with cervical injuries for its so-called Pathway trial. This is a Phase II trial that will be more formal than the thoracic studies to date: it will be randomized, controlled, single-blind study. The primary efficacy outcome will measure changes in strength in the hands, arms and shoulders.

There are high hopes the cervical study might offer more meaningful functional recovery. Says Fehlings, the stem cells might elicit motor recovery not seen in the thoracic studies. "So if someone were to recover motor function -- a segment or two or three or four -- depending on the level of injury, it might mean that they could recover upper arm function or even possibly hand function," he said. "And that could have a big impact in terms of people's quality of life."

Patients are being actively recruited in Milwaukee, Pittsburgh and Baltimore. The company says the trial will also expand to Los Angeles, Salt Lake City, Houston and Philadelphia.
 
Here are the eligibility criteria for the Pathway study:
  • cervical spinal cord injury that is classified as AIS grade A, B, or C
  • less than two years since injury occurred
  • general good health
For information on the Pathway study, click here.
 
Posted by Sam Maddox on May 18, 2015 10:09 PM America/New_York

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