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Stem Cell Transplants Found Safe for Spinal Cord Injuries

Spine model

(Michael Dorausch, Flickr)

1 June 2018. Results from a clinical trial testing transplants of neural stem cells for spinal cord injuries show the therapies are safe for patients, with signs of improvement in most participants 1 to 2 years after treatment. The findings from a team at University of California in San Diego appear in today’s issue of the journal Cell Stem Cell (paid subscription required).

Spinal cord injuries are often caused by a sudden, traumatic blow to the spine that bruises or tears into spinal cord tissue, resulting in fractures or compression to vertebrae, or in some cases severing the spinal cord. Depending on severity, people with spinal cord injuries often suffer loss of feeling or motor function in the limbs, and in some cases complete paralysis. According to the National Spinal Cord Injury Statistical Center, spinal cord injuries occur in 54 out of 1 million people in the U.S., adding some 17,500 new cases each year.

The UC-San Diego team led by neurosurgery professor Joseph Ciacci is testing an experimental treatment for spinal cord injuries, particularly in chronic cases where the injuries continue for longer than 6 months. The treatments are given as transplants from neural stem cell lines developed by biotechnology company Neuralstem Inc. in Germantown, Maryland. Neuralstem says the stem cell line, code-named NSI-566, helps create new spinal cord nerve cells that transmit signals from the brain to points in the body at or below the injury site.

The clinical trial enrolled 4 individuals with spinal cord injuries occurring 1 to 2 years earlier, with enrollment still open for 4 more participants. The early-stage study is looking mainly at the safety of the Neuralstem treatments, particularly reports of adverse effects in the first 6 months. Participants are also tracked for 5 years for signs of the stem cell grafts’ survival, as well as immune system reaction to the transplants. The trial has no control or comparison group.

Ciacci and colleagues say after 18 to 27 months following the transplants, the procedures were well tolerated and none of the participants reported serious adverse effects. While efficacy measures were not part of the original trial protocol, the researchers say 3 of the 4 participants show at least some improvement in neural functions. In addition, 2 of the 4 participants show 1 to 2 levels of improvement on standard sensory and motor assessment rating scales for spinal cord injury patients.

The researchers emphasize the results reflect a small sample size, as well as no control or comparison group. Nonetheless they consider the results encouraging and recommend larger-scale tests of higher stem cell doses, both for safety and if they accelerate repair and recovery.

Neuralstem is also assessing its NSI-566 stem cells in patients with amyotrophic lateral sclerosis, or ALS. As reported in Science & Enterprise in March 2015, clinical trial results show ALS patients receiving transplants with NSI-566 cells nearly stopped their functional decline, and in some cases improved their muscle functions.

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