TY - CHAP
T1 - Clinical trials
T2 - Noncellular regenerative approaches
AU - Senthilnathan, Vjura
AU - Punjani, Nayaab
AU - Nagoshi, Narihito
AU - Ahuja, Christopher S.
AU - Fehlings, Michael G.
N1 - Publisher Copyright:
© 2022 Elsevier Inc. All rights reserved.
PY - 2022/1/1
Y1 - 2022/1/1
N2 - This chapter will provide an overview of the current noncellular regenerative therapies used in clinical trials as part of treating spinal cord injury (SCI). These methods include the use of antibodies, growth factors, minerals, drugs, biomaterials, and electrical stimulation, which aim to assist the endogenous regenerative circuitry to promote repair and replacement of cellular loss and axonal discontinuity. Most treatments demonstrate safety and feasibility for implementation in SCI; however, further testing is still required to determine efficacy in different clinical subpopulations. This chapter delves into clinical trial phases one to three, as well as humanitarian device exemption studies, with a focus on those from North America, Europe, Japan, and Australia. The trial objectives, main inclusion criteria, and available published results are examined.
AB - This chapter will provide an overview of the current noncellular regenerative therapies used in clinical trials as part of treating spinal cord injury (SCI). These methods include the use of antibodies, growth factors, minerals, drugs, biomaterials, and electrical stimulation, which aim to assist the endogenous regenerative circuitry to promote repair and replacement of cellular loss and axonal discontinuity. Most treatments demonstrate safety and feasibility for implementation in SCI; however, further testing is still required to determine efficacy in different clinical subpopulations. This chapter delves into clinical trial phases one to three, as well as humanitarian device exemption studies, with a focus on those from North America, Europe, Japan, and Australia. The trial objectives, main inclusion criteria, and available published results are examined.
KW - AIS grade
KW - Biomaterials
KW - Clinical trials
KW - Functional electrical stimulation (FES)
KW - Regeneration
KW - Small molecules
KW - Spinal cord injury (SCI)
UR - http://www.scopus.com/inward/record.url?scp=85130659385&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130659385&partnerID=8YFLogxK
U2 - 10.1016/B978-0-12-819835-3.00001-0
DO - 10.1016/B978-0-12-819835-3.00001-0
M3 - Chapter
AN - SCOPUS:85130659385
SN - 9780128198360
SP - 473
EP - 500
BT - Neural Repair and Regeneration after Spinal Cord Injury and Spine Trauma
PB - Elsevier
ER -