BACKGROUND: Changing the local environment of spinal injury promotes the repair and regeneration of injured nerve and recovery of partial nervous function of spinal cord. Transplantation of olfactory ensheathing cells can improve the local internal environment of injured spinal cord.OBJECTIVE: To probe into the effect and safety of transplantation of olfactory ensheathing cells on functional repair of spinal cord and nerve in patients with obsolete spinal injury DESIGN: Self-control experiment.SETTING: Wards of the Department of Surgery, Taian Rongjun Hospital of Shandong Province.PARTICIPANTS: Totally 48 patients admitted for obsolete spinal injury in the Department of Surgery, Taian Rongjun Hospital, between June 2004 and July 2005 were recruited. There were 39 males and 9 females, aged 7 to 59 years with the mean of 36 years.METHODS: ①Cell culture: Olfactory bulb of aborted fetus was digested into single olfactory ensheathing cells, which were then cultured and puri fied for 1 to 2 weeks, and finally made into single cell suspension. ②Operation and cell transplantation: Under general anesthesia, the purified single cell suspension (about 0.05-0.20 mL) of olfactory ensheathing cells was injected into the corresponding spinal injury site through multiple points with home-made syringe of 0.45 mm in diameter. Stitches were taken out at postoperative 10 to 14 days. ③Evaluation of spinal function: Injury Scoring Standard made by American Spinal Injury Association (ASIA) was used for scoring, comparison and statistical analysis at postoperative 1 day and 2 weeks to 2 months. ④Spinal function of 48 patients was observed or followed up through telephone at postoperative 3 weeks to 1 year.MAIN OUTCOME MEASURES: Changes of postoperative sensory function of the patients. Changes of postoperative motor function of the patients. Changes of postoperative automatic nervous system of the patients.RESULTS: ①All the 48 patients had improvement in spinal function, and continued improved tendency was found in the observation and follow-up through telephone at postoperative 3 weeks to 1 year. ②Scoring by ASIA for sensory function was higher after operation than before operation (touch sensation: 56.9, 51.2, P ＜ 0.01; pain sensation: 55.2, 48.3, P ＜ 0.01). Sensory function was improved obviously at the lower shift of sensory level,generally more than 2 segments. ③Scoring by ASIA for motor function was higher after operation than before operation (44.8, 40.7, P ＜ 0.01), but the improvement was slow. ④Scoring by ASIA for automatic nervous system was higher after operation than before operation (18.0, 14.5, P ＜ 0.01); diaphoresis, increased enterokinesia and other automatic nervous system improved earliest.CONCLUSION: Transplantation of olfactory ensheathing cells promotes the spinal and neurofunctional recovery of patients with malignant spinal injury, and the therapeutic method is safe.

0.05),but the level of P- selectin in treatment group were obviously decreased compared with control group after the seventh and fourteenth day(P

Objective:To affirm the importance of clinical trial kick-off meeting and improve the meeting quality.Methods:According to the literature review of latest laws and regulations, combined with working experiences in clinical trial management, this article tried to identify possible problems that might occur before, during and after the kick-off meeting, analyze how to better manage the kick-off meeting, and propose suggestions for possible solutions.Results:Newly approved clinical trial institutions may face challenges such as lack of training, unclear responsibilities, lack of attention to quality control of professional department and post-meeting management. Thus, a series of suggestions were proposed, including more substantial communication and tailored training should be in place before the kick-off meeting, responsibilities for each stakeholder should be clarified during the meeting with specific concern of the professional quality control, in addition, meeting minutes and related materials should be well documented after the meeting.Conclusions:Clinical trial kick-off meeting is crucial that clinical trials institutions should pay more attention and work for better administration of such meetings.