A Prospective Randomized Double-Blind Clinical Trial Using a Combination of Olfactory Ensheathing Cells and Schwann Cells for the Treatment of Chronic Complete Spinal Cord Injuries

Cell Transplantation

Article

Juan Xiao¹  Yancheng Liu¹  Di Chen¹  Haitao Xi¹  Hongyun Huang²  Feng Zhang²  Lin Chen³ 

[1] Center of Neurorestoratology, Beijing Rehabilitation Hospital, Capital Medical University, Beijing, China;Center of Neurorestoratology, Beijing Rehabilitation Hospital, Capital Medical University, Beijing, China;Beijing Hongtianji Neuroscience Academy, Beijing, China;Center of Neurorestoratology, Beijing Rehabilitation Hospital, Capital Medical University, Beijing, China;Beijing Hongtianji Neuroscience Academy, Beijing, China;Medical Center, Tshinghua University, Beijing, China;

关键词: Olfactory ensheathing cells (OECs);    Schwann cells (SCs);    Spinal cord injury (SCI);    Transplantation;    Clinical trial;   

DOI  :  10.3727/096368914X685014

 received in 2014-03-12, accepted in 2014-10-09,  发布年份 2014

来源: Sage Journals

【 摘 要 】

The aim of this prospective randomized double-blind clinical study is to examine the benefits of using olfactory ensheathing cells (OECs) combined with or without Schwann cells (SCs) in treating chronic complete spinal cord injuries (SCIs). This would offer patients a better alternative for neurological functional recovery. According to the initial design, 28 eligible participants with cervical chronic complete SCI were recruited and randomly allocated into four groups of seven participants each. The neurological assessments were to be performed according to the American Spinal Injury Association (ASIA) and International Association of Neurorestoratology (IANR) Functional Rating Scales, in combination with electrophysiological tests, for example, electromyography (EMG) and paraspinal somatosensory evoked potentials (PSSEPs). Here we have summarized the data from seven patients; three patients received an OEC intraspinal transplantation, one underwent SC implantation, and one received a combination of OECs and SCs. The remaining two patients were used as controls. The scores were evaluated independently by at least two neurologists in a blinded fashion for comparing the neurological functional changes during pre- and post-cell transplantation (6-month follow-up). All patients who received OECs, SCs alone, and a combination of them showed functional improvement. Mild fever occurred in one of the patients with OEC transplant that subsided after symptomatic treatments. All treated patients except one showed improvement in the electrophysiological tests. The functional improvement rate comprises 5/5 (100%) in the treated group, but 0/2 (0%) in the control group (p = 0.008). These preliminary findings show that transplanting OECs, SCs, or a combination of them is well tolerated and that they have beneficial effects in patients. Thus, further studies in larger patient cohorts are warranted to assess the benefits and risks of these intervention strategies. This manuscript is published as part of the IANR special issue of Cell Transplantation.

【 授权许可】

Unknown   
© 2014 Cognizant Comm. Corp.

【 图 表 】

Figure 2.

Figure 2.