bone marrow cells have long been studied by scientists in the treatment of hematologic diseases. Moreover, some studies have found out that bone marrow cells can be differentiated into neurons and glial cells when induced under experimental conditions. In recent years, transplantation of autologous bone marrow transplantation as a potential source of progenitor cells in patients with spinal cord injury has been studied in clinical trials around the world. In Hospital São Rafael, Salvador, Brazil, Ricardo dos Santos and his team initiated a Phase I clinical trial in July 2010 that is investigating the feasibility and safety of autologous bone marrow stem cell transplantation in patients with spinal cord injury. Likewise, Andrés Chahín and his team are conducting a phase II clinical trial in Clínica Las Condes, Santiago, Chile, to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury. The research team believes that this study will provide more data on the potential improvement of sphincter controls and muscular strength with the transplantation of mesenchymal stem cells.
In December 2010, StemCells Inc. received authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a phase I/II clinical trial of its HuCNS-SC product (human neural stem cells) in patients with spinal cord injury. This interventional study was initiated at Balgrist University Hospital, University of Zurich and is being chaired by Stephen Huhn and his team in Zurich, Switzerland. This Phase I/II clinical trial will evaluate the safety and preliminary effects of single intramedullary transplantation of HuCNS-SC into the thoracic spinal cord of patients with subacute spinal cord injury. This clinical trial was initiated in March 2011 and its estimated completion date is March 2016.
To date, no official results have been issued, but data from three patients who completed the trial in December 2012 showed that two patients displayed some multi-segment gains in sensory function 12 months post transplantation of HuCNS-SC. One of these two patients converted from a complete injury classification to an incomplete injury, while the third patient remained stable. The research team believes that the study has given an excellent safety profile and encouraging results to date and they have amended the research protocol to allow continued enrollment of patients with complete injury in addition to patients with less severe or incomplete injury.
Based on this safety profile, on June 3, 2013, Health Canada authorized StemCells Inc. to expand its clinical trial into Canada. Following the approval, a team of doctors headed by Steven Casha at the University of Calgary successfully performed a stem cell transplant in an SCI patient in January 2014. Neural stem cells were injected into the spine of a 29-year-old paraplegic male, who will now be monitored to determine whether implanting those cells is safe. At present (2014), StemCells Inc. has nine patients enrolled in this study and plans to enroll 12 more subjects who have been paralyzed from the chest down. Apart from the Balgrist University Hospital in Zurich, Switzerland, and University of Calgary, patients are being enrolled at the University of Toronto (UT) with Michael Fehlings, head of the spinal program at Toronto Western Hospital, as the lead investigator for the trial at UT.
After obtaining Food and Drug Administration (FDA) approval to initiate a Phase I, multisite safety trial of the human spinal cord–derived neural stem cell labeled NSI-566 neural stem cells for chronic spinal cord injury (cSCI) in the United States, Neuralstem is also seeking to study NSI-566 in patients with acute SCI. For this purpose, a phase 1/2 study is expected to commence in 2014 in Seoul, South Korea, in collaboration with partner CJ CheilJedang. The trial will be similar in design to the chronic SCI trial being carried out in the United States, only enrolling 8 to 10 patients with acute injury hours after the traumatic event.
Stem cell therapy does offer a glimmer of hope to patients whose injuries have long been considered untreatable. Can stem cell therapy potentially enhance the quality of life of those affected by SCI? This still remains to be proven in humans. Though the answer seems to be a long way ahead right now, it is essential nonetheless for people with spinal cord injuries to know that there is potential hope on the horizon and that there are efforts under way right now to move forward toward a possible cure.
Syed A. Quadri
Desert Regional Medical Center, Palm Springs
Shariq Nawab
Sajid S. Suriya
Fahad Mehmood
Dow University of Health Sciences
Muhammad Junaid Uddin Zaheer
Aga Khan University Hospital
See Also: Adult StemCells: Overview; Bone Marrow Transplants; Canada: Stem Cell Network; Clinical Trials, U.S: Spinal Cord Injury; Neuralstem, Inc.; Spinal Cord Injury; Swiss Stem Cells Network; University of Toronto.
Further Readings
Antonic, A., E. S. Sena, J. S. Lees, T. E. Wills, P. Skeers, et al. “Stem Cell Transplantation in Traumatic Spinal Cord Injury: A Systematic Review and Meta-Analysis of Animal Studies.” PLoS Biology, v.11/12 (2013).
California Institute for Regenerative Medicine. http://www.cirm.ca.gov (Accessed June 2014).
ClinicalTrials.gov. U.S. National Institutes of Health. http://www.clinicaltrials.gov/show/NCT01321333 (Accessed June 2014).
ClinicalTrials.gov. U.S. National Institutes of Health. http://www.clinicaltrials.gov/show/NCT01325103 (Accessed June 2014).
ClinicalTrials.gov. U.S. National Institutes of Health. http://www.clinicaltrials.gov/show/NCT01694927 (Accessed June 2014).
Geron Corporation. http://www.geron.com (Accessed June 2014).
Ha, Y., D. H. Yoon, D. S. Yeon, H. O. Kim, et al. “Neural Antigen Expressions in Cultured Human Umbilical Cord Blood Stem Cells In Vitro.” Journal of Korean Neurosurgical Society, v.30 (2001).
Munoz-Elias, G., D. Woodbury, and I. B. Black. “Marrow Stromal Cells, Mitosis, and Neuronal Differentiation: Stem Cell and Precursor Functions.” Stem Cells, v.21 (2003).
Park, Hyung C., Yoo S. Shim, Yoon Ha, Seung H. Yoon, Byung H. Choi, and Hyun S. Park. “Treatment of Complete Spinal Cord Injury Patients by Autologous Bone Marrow Cell Transplantation and Administration of Granulocyte-Macrophage Colony Stimulating Factor.” Tissue Engineering, v.11/5–6 (2005).
Sanchez-Ramos, J., S. Song, F. Cardozo-Pelaez, C. Hazzi, et al. “Adult Bone Marrow Stromal Cells Differentiate Into Neural Cells In Vitro.” Experimental Neurology, v.164 (2000).
Stem Cell Network. http://www.stemcellnetwork.ca (Accessed June 2014).
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