Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial

Mohamad Bydon (), Wenchun Qu, F. M. Moinuddin, Christine L. Hunt, Kristin L. Garlanger, Ronald K. Reeves, Anthony J. Windebank, Kristin D. Zhao, Ryan Jarrah, Brandon C. Trammell, Sally El Sammak, Giorgos D. Michalopoulos, Konstantinos Katsos, Stephen P. Graepel, Kimberly L. Seidel-Miller, Lisa A. Beck, Ruple S. Laughlin and Allan B. Dietz
Additional contact information
Mohamad Bydon: Mayo Clinic
Wenchun Qu: Mayo Clinic
F. M. Moinuddin: Mayo Clinic
Christine L. Hunt: Mayo Clinic
Kristin L. Garlanger: Mayo Clinic
Ronald K. Reeves: Mayo Clinic
Anthony J. Windebank: Mayo Clinic
Kristin D. Zhao: Mayo Clinic
Ryan Jarrah: Mayo Clinic
Brandon C. Trammell: Mayo Clinic
Sally El Sammak: Mayo Clinic
Giorgos D. Michalopoulos: Mayo Clinic
Konstantinos Katsos: Mayo Clinic
Stephen P. Graepel: Mayo Clinic
Kimberly L. Seidel-Miller: Mayo Clinic
Lisa A. Beck: Mayo Clinic
Ruple S. Laughlin: Mayo Clinic
Allan B. Dietz: Mayo Clinic

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract 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.

Date: 2024
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DOI: 10.1038/s41467-024-46259-y

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