How are the stem cells identified, isolated, and grown? Are the cells differentiated into specialized cells before therapy? How do I know if the cells are delivered to the right part of my body? If the cells are not my own, how will my immune system be prevented from reacting to the transplanted cells? What do the cells actually do, and is there scientific evidence that this procedure could work for my disease or condition?
Where is this published? Related pages What is a complete vs incomplete injury? What emergency procedures occur following an SCI? How do I deal with depression and adjustment to my SCI? What are the secondary conditions? I have no health insurance, what are my options?
One pitfall that should be emphasized is that most of these clinical trials are single-centered, investigator-oriented trials. Clinical trials aiming to obtain drug approval are more highly restrictive and include external monitoring to assure good laboratory practices, good clinical practices, and good manufacturing practices established for each country.
However, these procedures are often very expensive and differ between countries, which increase the trial threshold for clinical trials. The standardization of the regulations between agencies, such as the United States Food and Drug Administration and the European Medicines Agency, is warranted.
The heterogeneous results of clinical trials using stem cells for SCI treatment suggest a need for further assessment and basic experimentation.
The biggest movement of clinical trials is that the trials are moving from investigator-oriented academic research to profit-oriented, company-funded research. The results of the studies, as well as their cost effectiveness, will be key to the future development of stem cell research. Conceptualization, M. All authors have read and agreed to the published version of the manuscript. National Center for Biotechnology Information , U.
Int J Mol Sci. Published online Jun 2. Author information Article notes Copyright and License information Disclaimer. Received Apr 26; Accepted May This article has been cited by other articles in PMC. Abstract There are more than one million patients worldwide suffering paralysis caused by spinal cord injury SCI.
Keywords: stem cell, spinal cord injury, neurogenesis, inflammation, regenerative medicine, transplantation. Introduction Spinal cord injury SCI is mainly caused by severe trauma from traffic accidents, falls, and sports-related injuries, and there are more than one million patients worldwide suffering from SCI-related paralysis.
Open in a separate window. Figure 1. Figure 2. Mechanisms of Action of Stem Cell Transplantation Extensive efforts have been applied to elucidate the mode of action of stem cell transplantation in treating SCI, and multiple descriptive reviews have been published [ 61 , 62 ].
Key Segment of Clinical Trials 4. Table 1 List of published clinical trials. Acute Phase of SCI Given that most of the animal preclinical experiments are conducted at the acute phase within 24 h of the injury [ 61 ], the lack of acute-phase clinical trials is somewhat surprising. Chronic Phase of SCI The majority of clinical trials are conducted in the chronic phase, when hope for a spontaneous recovery is minimal. Hematopoietic Stem Cells Hematopoietic stem cells expressing CD34 and from both the bone marrow and peripheral blood are also relatively frequently used in clinical trials of SCI treatment [ 23 , 26 , 28 , 35 , 43 ].
OECs OECs surround olfactory neurons, with their presumed function as scavengers of pathogens and debris around the border between the central nervous system CNS and the nasal mucosa. Schwann Cells Schwann cells act as structural scaffolds for the peripheral nervous system and can promote a microenvironment favorable to neuronal regeneration. NSCs NSCs are self-renewing, multipotent progenitor cells capable of differentiating into neural cells, oligodendrocytes, and astrocytes [ , ].
Cell Dose and Route Cell dose is among the most important clinical variables; however, it is difficult to determine the optimal dose in humans from the results of animal experiments because of the differences in body weight and spinal cord size.
Table 2 Animal experiments comparing the efficacy of different cell administration routes. Patient Characteristics and Outcome Measures The ASIA impairment scale is the most frequently used metric for determining study inclusion, and often, only patients with the ASIA A impairment level complete motor and sensory loss below the level of injury are included in the trials. Results, Pitfalls, and Future Directions Aside from the large number of experimental studies, clinical trials associated with SCI remains in its infancy.
Conclusions The heterogeneous results of clinical trials using stem cells for SCI treatment suggest a need for further assessment and basic experimentation. Author Contributions Conceptualization, M. Conflicts of Interest The authors declare no conflicts of interest.
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Legal Options. About Us. Learn More About SpinalCord. Contact Us. Copyright All Rights Reserved. Spinal Cord, Inc. Sponsored by Swope, Rodante P. Swope Law. The information provided by SpinalCord. She was devastated, assuming her life was over, and because of this, she decided to enroll in a new clinical trial. However, the benefits proved much greater than the dangers, because today Sonia can walk, talk, and function normally.
She has a child and a new life, all because of stem cells. Once inside her brain, the stem cells went to work identifying damaged nerves and replacing them with new ones. Luckily, Sonia is not the only one. Researchers are hard at work identifying new treatments. This database is estimated to contain nearly three-quarters of clinical trials worldwide.
Nine of these studies are actively recruiting patients.
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