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Will StemCells Walk The Talk?

March 7th, 2012 2:01 pm

3/7/2012 5:12 AM ET (RTTNews) - Stem cells have set the scientific world agog because it has been proposed as candidates to treat a myriad of diseases ranging from alzheimer's to arthritis, blindness, burns, cancer, diabetes, heart disease, liver disorders, multiple sclerosis, parkinson's, spinal cord injury and stroke.

Engaged in the development of novel stem cell therapeutics targeting diseases of the central nervous system and liver is clinical-stage company StemCells Inc. (STEM: News ).

For readers who are new to this Palo Alto, California-based company, here's what to expect in the coming months...

StemCells' lead product candidate is HuCNS-SC cells, a highly purified composition of human neural stem cells, currently in clinical development for spinal cord injury and for Pelizaeus-Merzbacher Disease, or PMD, a fatal myelination disorder in children.

A phase I/II clinical trial of HuCNS-SC cells in chronic spinal cord injury was initiated by the company last March. The trial, which is the world's first neural stem cell trial in spinal cord injury, is designed to enroll patients with thoracic (chest-level) neurological injuries with progressively decreasing severity of injury in three sequential cohorts.

The first patient in the trial was successfully transplanted with the company's proprietary HuCNS-SC adult neural stem cells last September, and enrollment in the first cohort of the spinal cord injury trial was completed last December. Following transplantation, the patients are being evaluated regularly over a 12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells.

The trial, which is currently open for enrollment for the remaining cohorts, is being conducted in Switzerland at the Balgrist University Hospital, University of Zurich.

In November 2011, Geron Corp. (GERN), the first company to get FDA approval for a clinical trial of an embryonic stem cell-based therapy, abandoned its phase I stem cell trial in patients paralyzed by spinal cord injuries - largely because of financial reasons.

The difference between the spinal cord injury trials of StemCells and Geron lies in the type of stem cells being evaluated. While Geron used human embryonic stem cells to treat spinal cord injuries in its trial, StemCells is using tissue-derived "adult" (non-embryonic) stem cells in its trials.

Yet another trial of StemCells that is underway is a phase I trial evaluating the safety and preliminary efficacy of HuCNS-SC cells as a treatment for Pelizaeus-Merzbacher Disease that primarily affects infants and young children.

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Will StemCells Walk The Talk?

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