Abraham Mickey, Shalom Moshe, Gold Justin, Seaton Margaret, Maleski Smith Alina, Gendreau Julian, Brandel Michael G, Ciacci Joseph
Department of Neurosurgery, University of California San Diego, La Jolla, California, USA.
Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel.
World Neurosurg. 2024 Nov;191:e116-e125. doi: 10.1016/j.wneu.2024.08.074. Epub 2024 Aug 17.
Spinal cord injury (SCI) affects around 18,000 individuals annually, representing nearly one-third of all paralysis cases. Stem cell therapy, a focal point in contemporary neuroregeneration research for SCI treatment, holds potential in leveraging undifferentiated stem cells to regenerate damaged tissues. This study seeks to comprehensively analyze current clinical trials exploring the potential use of stem cells in treating spinal cord injuries.
A data retrieval approach examined the ClinicalTrials.gov database using the terms "spinal cord injury" and "stem cells." Exclusion criteria eliminated studies not recruiting, terminated prematurely, suspended, withdrawn, or of unknown status. Data for each trial, including ClinicalTrial.gov NCT identifier, title, intervention details, initiation/completion dates, and sample size, were systematically collected. Literature searches on PubMed.gov were conducted for completed trials with results.
Thirty clinical trials were analyzed, with 20 completed and six with published results on PubMed.gov. Interventions included 20 biological (66.7%), 6 procedural (20%), and 4 drug interventions (13.3%). Stem cell sources varied, including bone marrow (46.7%), umbilical cells (20%), adipose tissue (20%), embryonic cells (6.7%), and neural cells (6.7%). Trials spanned 2005 to 2022, with 11 (36.7%) commencing in or after 2017. Among six trials with results, 50% used bone marrow-derived stem cells.
The promising potential of stem cells in neuroregenerative SCI treatment necessitates further exploration through large-scale, multicenter clinical trials to enhance understanding and guide wider adoption of this emerging treatment paradigm.
脊髓损伤（SCI）每年影响约18000人，占所有瘫痪病例的近三分之一。干细胞疗法是当代脊髓损伤神经再生研究的重点，有望利用未分化的干细胞再生受损组织。本研究旨在全面分析当前探索干细胞治疗脊髓损伤潜在用途的临床试验。
采用数据检索方法，使用“脊髓损伤”和“干细胞”等术语在ClinicalTrials.gov数据库中进行检索。排除标准排除了未招募、提前终止、暂停、撤回或状态不明的研究。系统收集了每个试验的数据，包括ClinicalTrials.gov的NCT标识符、标题、干预细节、开始/完成日期和样本量。对PubMed.gov进行文献检索，以获取已完成试验的结果。
分析了30项临床试验，其中20项已完成，6项在PubMed.gov上发表了结果。干预措施包括20项生物干预（66.7%）、6项程序干预（20%）和4项药物干预（13.3%）。干细胞来源各不相同，包括骨髓（占46.7%）、脐带细胞（占20%）、脂肪组织（占20%）、胚胎细胞（占6.7%）和神经细胞（占6.7%）。试验时间跨度为2005年至2022年，其中11项（36.7%）于2017年或之后开始。在六项有结果的试验中，50%使用了骨髓来源的干细胞。
干细胞在脊髓损伤神经再生治疗中的潜力巨大，有必要通过大规模、多中心临床试验进行进一步探索，以加深理解并指导这种新兴治疗模式的更广泛应用。
