Zamani Homa, Soufizomorrod Mina, Oraee-Yazdani Saeed, Naviafar Dariush, Akhlaghpasand Mohammadhosein, Seddighi Afsoun, Soleimani Masoud
Department of Cell Therapy and Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Functional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Spinal Cord. 2022 Jan;60(1):63-70. doi: 10.1038/s41393-021-00687-5. Epub 2021 Sep 9.
This is a phase I clinical trial.
Our objective was to assess the safety and feasibility of autologous mucosal olfactory ensheathing cell (OEC) and bone marrow mesenchymal stem cell (MSC) co-transplantation in people with chronic, complete (American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A) spinal cord injury (SCI).
This study was performed at Shohada Tajrish Hospital, Tehran, Iran.
Three individuals with the traumatic SCI of the thoracic level were enrolled. They received the autologous OEC and MSC combination through the lumbar puncture. All adverse events and possible functional outcomes were documented performing pre- and post-operative general clinical examination, magnetic resonance imaging (MRI), neurological assessment based on the International Standard of Neurological Classification for SCI, and functional evaluation using Spinal Cord Independence Measure version III (SCIM III).
No serious safety issue was recorded during the 2 years of follow-up. MRI findings remained unchanged with no neoplastic tissue formation. AIS improved from A to B in one of the participants. SCIM III evaluation also showed some degrees of progress in this participant's functional ability. The two other research participants had negligible or no improvement in their sensory scores without any changes in the AIS and SCIM III scores. No motor recovery was observed in any of the participants.
Overall, this 2-year trial was not associated with any adverse findings, which may suggest the safety of autologous OEC and bone marrow MSC combination for the treatment of human SCI.
这是一项I期临床试验。
我们的目的是评估自体黏膜嗅鞘细胞（OEC）和骨髓间充质干细胞（MSC）联合移植治疗慢性完全性（美国脊髓损伤协会（ASIA）损伤分级（AIS）分类为A）脊髓损伤（SCI）患者的安全性和可行性。
本研究在伊朗德黑兰的Shohada Tajrish医院进行。
纳入3例胸段创伤性SCI患者。他们通过腰椎穿刺接受自体OEC和MSC联合移植。通过术前和术后的一般临床检查、磁共振成像（MRI）、基于国际脊髓损伤神经分类标准的神经学评估以及使用脊髓独立测量量表第三版（SCIM III）进行功能评估，记录所有不良事件和可能的功能结果。
在2年的随访期间未记录到严重的安全问题。MRI检查结果无变化，未形成肿瘤组织。其中1例参与者的AIS从A改善为B。SCIM III评估也显示该参与者的功能能力有一定程度的进步。另外2例研究参与者的感觉评分改善可忽略不计或无改善，AIS和SCIM III评分无变化。所有参与者均未观察到运动功能恢复。
总体而言，这项为期2年的试验未出现任何不良结果，这可能表明自体OEC和骨髓MSC联合移植治疗人类SCI具有安全性。
