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US clinical trial to investigate safety of stem cell transplantation in spine

Researchers at the University of California, San Diego School of Medicine have launched a trial to investigate the safety of using human stem cells to treat patients with chronic spinal cord injury.

Go to the profile of Alexandra Thompson
Aug 13, 2014
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Go to the profile of Chris Mason
Chris Mason over 3 years ago

Link to the ClinicalTrials.gov database for this study - "Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI" - https://clinicaltrials.gov/ct2/show/NCT01772810

Sponsor:
Neuralstem Inc.

Primary Outcome Measures:
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. ] [ Designated as safety issue: Yes ]
The primary outcome measure is the incidence of adverse events in the study population.

Secondary Outcome Measures:
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. ] [ Designated as safety issue: Yes ]
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).