| Objective:1.Confirm the safety and validity of using enriched autologous bone marrow mesenchymal stem cells(BMSCs)seeded gelatin sponge for repairing IVD defect generated by discectomy.2.Confirm the profit of degeneration restraining through annular fibrosus(AF)suture,evaluate it’s long-term therapeutic effect.Methods:45 patients with symptomatic lumbar disc herniation were recruited voluntary from a single center(Tianjin Hospital)since December 2016 to December 2017,written informed consent was obtained from each study subjects.All patients accepted discectomy treatment using MMED under general anesthesia and were randomly divided into 3 groups according to the random number table with different treating strategies:(1)MMED group: patients treated with MMED alone as the control group(n=15,9 males and 6 females);(2)MMED+AFS group:after MMED process,the defect of AF was sutured by a disposable annular stapler(n= 15,11 males and 4 females);(3)MMED+AFS+BMSCs group: after MMED,30 ml of BMA was harvested from posterior superior iliac crest,the effective constituent in BMA was enriched and seeded into gelatin sponge pieces.Then the BMSCs seeded gelatin sponge was inserted into the defect of intervertebral disc under MMED before AF defect was sutured(n= 15,8 males and 7 females).A 2-years postoperative follow-up was performed.The protocol included 5 visits respectively carried out in preoperative,postoperative 3 months,6 months,12 months and 24 months.Evaluate the changes in patient-reported outcomes of VAS,ODI and SF-36 scores.Disc repair effect according to magnetic resonance imaging with Pfirrmann grade,intervertebral disc height(IDH)and disc protrusion size was also measured.Results:No significant difference was found from the mean age,intraoperative blood loss and hospital stay(including postoperative rehabilitation time)between all groups.Mean pretreatment VAS score was 7.36±1.07,7.14±0.71 and 7.42±1.01 in MMED,MMED+AFS and MMED+AFS+BMSCs group;while mean ODI score was 61.2±17.4%,62.4±12.2% and 63.3±14.3% respectively.All patients achieved significant improvement at 3 months after treatment,and the improvement persisted even further until 24 months.At the final follow-up,VAS improvement rate of MMED+AFS+BMSCs group was significantly better than MMED group(80.1±7.6% vs 70.1±7.78%,P=0.03)and the MMED+AFS group(71.3±6.98%,P=0.03).Besides,MMED+AFS+BMSCs group also showed better ODI improvement rate than MMED+AFS and MMED group(65.6±8.8% vs 59.9±5.5% vs 57.8±8.1% P=0.05&0.04).All patients got a significant improvement in SF-36 PCS and MCS,no statistical difference was found between all groups.At 12 months’ follow-up,mean Pfirrmann Grade of MMED group was significantly decreased compared to preoperative status(4.06±0.67 to 4.63±0.49,P=0.03).At the final follow-up,mean Pfirrmann Grade of MMED+AFS group and MMED+AFS+BMSCs group was not significantly different to preoperative status.Mean IDH lost rate of the MMED+AFS+BMSCs group was significantly lower than the other two groups at 12 months after treatment,while IDH lost rate of MMED+AFS group was slightly lower than that of MMED Group(-17.2%±1.3% vs-20.6%±0.7% vs-29.3%±2.2%).During the follow-up period,DPS decreased more than 50% in all patients compared to preoperative status,and no recurrence of herniation occurred.Conclusion:Our research showed that it is feasible and effective to repair lumbar disc defects with BMSCs combined gelatin sponge,which is worthy of further study and improvement.Although AF suture did not present in a preconceived effectiveness,the closure of AF defect may conduce to prevent cell leakage. |
PDF Full Text Request