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

Author

Listed:
  • Mohamad Bydon

    (Mayo Clinic
    Mayo Clinic)

  • Wenchun Qu

    (Mayo Clinic)

  • F. M. Moinuddin

    (Mayo Clinic
    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
    Mayo Clinic)

  • Brandon C. Trammell

    (Mayo Clinic
    Mayo Clinic)

  • Sally El Sammak

    (Mayo Clinic
    Mayo Clinic)

  • Giorgos D. Michalopoulos

    (Mayo Clinic
    Mayo Clinic)

  • Konstantinos Katsos

    (Mayo Clinic
    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)

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.

Suggested Citation

  • 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 Samma, 2024. "Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial," Nature Communications, Nature, vol. 15(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-46259-y
    DOI: 10.1038/s41467-024-46259-y
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