Neuro-Informatics Laboratory, Mayo Clinic, Rochester, MN, USA.
Department of Neurological Surgery, Mayo Clinic, Rochester, MN, USA.
Nat Commun. 2024 Apr 1;15(1):2201. doi: 10.1038/s41467-024-46259-y.
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.
鞘内注射自体培养扩增的脂肪组织来源间充质干细胞(AD-MSC)可用于治疗创伤性脊髓损伤(SCI)。这项 I 期临床试验(ClinicalTrials.gov:NCT03308565)纳入了 10 名损伤时美国脊髓损伤协会损伤量表(AIS)分级为 A 或 B 的患者。该研究的主要终点是安全性概况,通过不良事件的性质和频率来捕获。次要终点包括感觉和运动评分、影像学、脑脊液标志物和体感诱发电位的变化。所有患者的方案制造和递送均成功。最常见的不良事件是头痛和肌肉骨骼疼痛,8 名患者出现上述症状。未观察到严重的 AE。在最终随访时,7 名患者在注射时的 AIS 分级有所改善。总之,该研究达到了主要终点,表明 AD-MSC 的采集和给药在创伤性 SCI 患者中具有良好的耐受性。
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