StemCells, Inc.
STEM today announced that the twelve-month data from the first
patient cohort in the Company's Phase I/II clinical trial of its proprietary
HuCNS-SC® product candidate (purified human neural stem cells) for chronic
spinal cord injury continued to demonstrate a favorable safety profile, and
showed that the considerable gains in sensory function observed in two of the
three patients at the six-month assessment have persisted. The third patient
remains stable. A summary of the data was presented today by Martin McGlynn,
President and CEO, at the 15^th Annual BIO CEO & Investor Conference. By
completing the twelve-month assessment, the first patient cohort has now
completed the trial, and has entered into a separate follow-up study for
long-term observation.
"The multi-segment gains observed in sensory function in two patients at six
months have endured at the 12-month assessment. In addition, between the six-
and 12-month evaluations, one patient converted from a complete to an
incomplete injury," said Armin Curt, M.D., Professor and Chairman of the
Spinal Cord Injury Center at Balgrist University Hospital, University of
Zurich and principal investigator of the clinical trial. "Importantly, the
persistence of these sensory gains at the 12-month evaluation was seen across
more than one clinical measure. While much more clinical research needs to be
done to demonstrate efficacy, the types of changes we are observing are
unexpected and very encouraging given that these are patients in the chronic
stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a
small, uncontrolled trial, to our knowledge, this is the first time a patient
with a complete spinal cord injury has been converted to a patient with an
incomplete injury following transplantation of neural stem cells. We are
encouraged that the cells appear to convey clinical benefit in such severely
injured patients. We are therefore hopeful that we will see similar or greater
benefit in AIS B and C patients, who already have partial sensation and motor
function below the level of injury which could be further augmented by cell
transplantation."
Patients in the study's first cohort all suffered a complete injury to the
thoracic (chest-level) spinal cord. In a complete injury, there is no
neurological function below the level of injury, and sensory function of all
three patients was stable before transplantation of the HuCNS-SC cells. All
three patients were transplanted four to nine months after injury with a dose
of 20 million cells at the site of injury. The surgery, immunosuppression and
the cell transplants have been well tolerated by all the patients. There were
no abnormal clinical, electrophysiological or radiological responses to the
cells, and all the patients have remained neurologically stable through the
first 12 months following transplantation. Positive changes in sensitivity to
touch, heat and electrical stimuli were observed in well-defined and
consistent thoracic regions in two of the patients, while no changes were
observed in the third patient. Importantly, quantitative tests of specific
sensory function, as well as electrophysiological measures of impulse
transmission across the site of injury, show an association with the
clinical examination, providing further objective confirmation of the sensory
gains.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC® purified human
adult neural stem cells is designed to assess both safety and preliminary
efficacy. Twelve patients with thoracic (chest-level) neurological injuries at
the T2-T11 level are planned for enrollment, and their injuries must have
occurred within three to twelve months prior to transplantation of the cells.
In addition to assessing safety, the trial will assess preliminary efficacy
based on defined clinical endpoints, such as changes in sensation, motor
function and bowel/bladder function. The Company has dosed the first three
patients, all of whom have injuries classified as AIS A, in which there is no
neurological function below the injury level. The injuries are classified
according to the American Spinal Injury Association Impairment Scale (AIS).
The second and third cohorts will be patients classified as AIS B and AIS C,
those with less severe injury, in which there is some preservation of sensory
or motor function.
All patients will receive HuCNS-SC cells through direct transplantation into
the spinal cord and will be temporarily immunosuppressed. Patients will be
evaluated regularly in the post-transplant period in order to monitor and
assess the safety of the HuCNS-SC cells, the surgery and the
immunosuppression, as well as to measure any recovery of neurological function
below the injury site. The Company intends to follow the effects of this
therapy long-term, and each of the patients will be invited to enroll into a
separate four year observational study after completing the Phase I/II study.
The trial is being conducted at Balgrist University Hospital, University of
Zurich, a world leading medical center for spinal cord injury and
rehabilitation, and is open for enrollment to patients in Europe, Canada and
the United States. Enrollment for the second cohort is currently underway, and
the first AIS B patient was enrolled and dosed late last year. If you believe
you may qualify and are interested in participating in the study, please
contact the study nurse either by phone at +41 44 386 39 01 or by email at
stemcells.pz@balgrist.ch.
Additional information about the Company's spinal cord injury program can be
found on the StemCells, Inc. website at
http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm,
including video interviews with Company executives and independent
collaborators.
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