Nav: Home

Stem cell-based phase I trial to repair spinal cord injuries produces encouraging results

June 01, 2018

Writing in the June 1 issue of Cell Stem Cell, researchers at University of California San Diego School of Medicine report that a first-in-human phase I clinical trial in which neural stem cells were transplanted into participants with chronic spinal cord injuries produced measurable improvement in three of four subjects, with no serious adverse effects.

"The primary purpose of this first trial was to assess safety. And no procedure-related complications were observed in any of the patients," said Joseph Ciacci, MD, principal investigator and a neurosurgeon at UC San Diego Health. "Our results suggest the approach can be performed safely and early signs of efficacy warrant further exploration and dose escalation studies."

The trial used a human spinal cord-derived neural stem cell line developed by Neuralstem, Inc, a biopharmaceutical company based in Maryland. Four trial participants with one- to two-year-old permanent injuries to T2-T12 thoracic vertebrae (located in the middle of the spine) received six injections, each containing 1.2 million neural stem cells.

In previous research, published in 2013 by Ciacci and co-author Martin Marsala, MD, professor in the Department of Anesthesiology at UC San Diego School of Medicine, stem cells were transplanted into rats with spinal cord injuries, resulting in neuronal regeneration and improvement in the animals' functioning and mobility.

In the latest human clinical trial, the results (measured 18 to 27 months after transplantation) were not dramatic, but encouraging. Analysis of motor and sensory function and electrophysiology results showed improvement in three of the four participants.

"This is a small sample size, but the real strengths of this study are the extensive follow-up period, electrophysiological assessments and the timeline of treatment. Everyone was treated after a year of injury, meaning there was essentially no chance of spontaneous recovery," said Ciacci. "Our primary objective was to provide proof of safety and tolerability of treatment. We've done that. These early signs of potential efficacy, combined with the promising results of earlier animal studies, argue for pressing ahead with new trials and greater doses to see if we can further accelerate repair and recovery."

A second clinical trial is in development. Its focus will be subjects with cervical injuries.
-end-
Co-authors include: Erik Curtis, Joel R. Martin, Brandon Gabel, Nikki Sidhu, Ross Mandeville, Sebastiaan Van Gorp, Marjolein Leerink, Takahiro Tadokoro, Silvia Marsala, and Martin Marsala, UC San Diego; Teresa K. Rzesiewicz, and Catriona Jamieson, UC San Diego and CIRM Alpha Stem Cell Clinic.

University of California - San Diego

Related Stem Cells Articles:

First events in stem cells becoming specialized cells needed for organ development
Cell biologists at the University of Toronto shed light on the very first step stem cells go through to turn into the specialized cells that make up organs.
Surprising research result: All immature cells can develop into stem cells
New sensational study conducted at the University of Copenhagen disproves traditional knowledge of stem cell development.
The development of brain stem cells into new nerve cells and why this can lead to cancer
Stem cells are true Jacks-of-all-trades of our bodies, as they can turn into the many different cell types of all organs.
Healthy blood stem cells have as many DNA mutations as leukemic cells
Researchers from the Princess Máxima Center for Pediatric Oncology have shown that the number of mutations in healthy and leukemic blood stem cells does not differ.
New method grows brain cells from stem cells quickly and efficiently
Researchers at Lund University in Sweden have developed a faster method to generate functional brain cells, called astrocytes, from embryonic stem cells.
More Stem Cells News and Stem Cells Current Events

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Rethinking Anger
Anger is universal and complex: it can be quiet, festering, justified, vengeful, and destructive. This hour, TED speakers explore the many sides of anger, why we need it, and who's allowed to feel it. Guests include psychologists Ryan Martin and Russell Kolts, writer Soraya Chemaly, former talk radio host Lisa Fritsch, and business professor Dan Moshavi.
Now Playing: Science for the People

#537 Science Journalism, Hold the Hype
Everyone's seen a piece of science getting over-exaggerated in the media. Most people would be quick to blame journalists and big media for getting in wrong. In many cases, you'd be right. But there's other sources of hype in science journalism. and one of them can be found in the humble, and little-known press release. We're talking with Chris Chambers about doing science about science journalism, and where the hype creeps in. Related links: The association between exaggeration in health related science news and academic press releases: retrospective observational study Claims of causality in health news: a randomised trial This...