间充质干细胞
脊髓损伤
脂肪组织
鞘内
脊髓
医学
干细胞
神经科学
生物信息学
麻醉
生物
细胞生物学
内科学
病理
作者
Mohamad Bydon,Wenchun Qu,F M Moinuddin,Christine Hunt,Kristin Garlanger,Ronald K. Reeves,Anthony J. Windebank,Kristin D. Zhao,Mohamad Bydon,Brandon C. Trammell,Sally El Sammak,George Michalopoulos,Konstantinos Katsos,Stephen Graepel,Kimberly L. Seidel-Miller,Lisa A. Beck,Ruple S. Laughlin,Allan B. Dietz
标识
DOI:10.1038/s41467-024-46259-y
摘要
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.
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