TY - JOUR
T1 - Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury
T2 - Phase I trial
AU - Bydon, Mohamad
AU - Qu, Wenchun
AU - Moinuddin, F. M.
AU - Hunt, Christine L.
AU - Garlanger, Kristin L.
AU - Reeves, Ronald K.
AU - Windebank, Anthony J.
AU - Zhao, Kristin D.
AU - Jarrah, Ryan
AU - Trammell, Brandon C.
AU - El Sammak, Sally
AU - Michalopoulos, Giorgos D.
AU - Katsos, Konstantinos
AU - Graepel, Stephen P.
AU - Seidel-Miller, Kimberly L.
AU - Beck, Lisa A.
AU - Laughlin, Ruple S.
AU - Dietz, Allan B.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - Intrathecal delivery of autologous culture-expanded adipose tissue-derived mesenchymal stem cells (AD-MSC) could be utilized to treat traumatic spinal cord injury (SCI). This Phase I trial (ClinicalTrials.gov: NCT03308565) included 10 patients with American Spinal Injury Association Impairment Scale (AIS) grade A or B at the time of injury. The study’s primary outcome was the safety profile, as captured by the nature and frequency of adverse events. Secondary outcomes included changes in sensory and motor scores, imaging, cerebrospinal fluid markers, and somatosensory evoked potentials. The manufacturing and delivery of the regimen were successful for all patients. The most commonly reported adverse events were headache and musculoskeletal pain, observed in 8 patients. No serious AEs were observed. At final follow-up, seven patients demonstrated improvement in AIS grade from the time of injection. In conclusion, the study met the primary endpoint, demonstrating that AD-MSC harvesting and administration were well-tolerated in patients with traumatic SCI.
AB - Intrathecal delivery of autologous culture-expanded adipose tissue-derived mesenchymal stem cells (AD-MSC) could be utilized to treat traumatic spinal cord injury (SCI). This Phase I trial (ClinicalTrials.gov: NCT03308565) included 10 patients with American Spinal Injury Association Impairment Scale (AIS) grade A or B at the time of injury. The study’s primary outcome was the safety profile, as captured by the nature and frequency of adverse events. Secondary outcomes included changes in sensory and motor scores, imaging, cerebrospinal fluid markers, and somatosensory evoked potentials. The manufacturing and delivery of the regimen were successful for all patients. The most commonly reported adverse events were headache and musculoskeletal pain, observed in 8 patients. No serious AEs were observed. At final follow-up, seven patients demonstrated improvement in AIS grade from the time of injection. In conclusion, the study met the primary endpoint, demonstrating that AD-MSC harvesting and administration were well-tolerated in patients with traumatic SCI.
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U2 - 10.1038/s41467-024-46259-y
DO - 10.1038/s41467-024-46259-y
M3 - Article
C2 - 38561341
AN - SCOPUS:85189102230
SN - 2041-1723
VL - 15
JO - Nature communications
JF - Nature communications
IS - 1
M1 - 2201
ER -