Hernigou Philippe, Flouzat Lachaniette Charles Henri, Delambre Jerome, Chevallier Nathalie, Rouard Helene
Orthopaedic Surgery, Hopital Henri Mondor, Créteil, France,
Int Orthop. 2014 Sep;38(9):1825-35. doi: 10.1007/s00264-014-2384-0. Epub 2014 Jun 7.
There is concern that regenerative cell-based therapies at the site of malignant primary bone tumours could result in increased risk of local tumour recurrence. We therefore investigated the long-term risks for site-specific recurrences in patients who had received an autologous bone marrow derived mesenchymal stem cell suspension to improve healing at the host-to-allograft bone junction of the reconstruction after bone tumour resection.
A total of 92 patients were treated from 1993 to 2003 with bone marrow-derived mesenchymal stem cells after bone tumour resection. Patients were monitored for cancer incidence from the date of first operation (1993) until death, or until 31 December 2013. The mean follow-up time was 15.4 years (range ten to 20 years). The average number of MSCs returned to the patient was 234,000 MSCs ± 215,000. The primary outcome was to evaluate the risk of tumorigenesis recurrence at the cell therapy treatment sites with radiographs and/or MRIs. The relative risk of cancer recurrence was expressed as the ratio of observed and expected number of cases according to three different control populations.
Thirteen recurrences were found at the treatment sites among the 92 patients. The expected number of recurrences based on incidence in the three cohort populations was between 15 and 20 for the same cancer, age and sex distribution. The standardized incidence ratio (equal to observed cancers divided by expected cancers) for the entire follow-up period and for all recurrences was between 0.65 and 0.86 (95 % CI 0.60-1.20).
This study found no increased cancer local recurrence risk in patients after application of autologous cell-based therapy using bone marrow-derived mesenchymal stem cells at the treatment site after an average follow-up period of 15.4 years, ranging from ten to 20 years.
人们担心在恶性原发性骨肿瘤部位进行基于再生细胞的治疗可能会增加局部肿瘤复发的风险。因此，我们调查了接受自体骨髓间充质干细胞悬液以改善骨肿瘤切除术后重建中宿主与同种异体骨连接处愈合的患者发生部位特异性复发的长期风险。
1993年至2003年共有92例患者在骨肿瘤切除术后接受了骨髓间充质干细胞治疗。从首次手术日期（1993年）起对患者进行癌症发病率监测，直至死亡或直至2013年12月31日。平均随访时间为15.4年（范围为10至20年）。回输给患者的间充质干细胞平均数量为234,000个±215,000个。主要结局是通过X线片和/或磁共振成像评估细胞治疗部位的肿瘤发生复发风险。根据三个不同的对照人群，癌症复发的相对风险表示为观察到的病例数与预期病例数之比。
92例患者中，在治疗部位发现13例复发。基于三个队列人群发病率的预期复发数，对于相同的癌症、年龄和性别分布，在15至20例之间。整个随访期及所有复发的标准化发病率（等于观察到的癌症数除以预期癌症数）在0.65至0.86之间（95%可信区间0.60 - 1.20）。
本研究发现，在平均随访15.4年（范围为10至20年）后，接受基于自体骨髓间充质干细胞的细胞治疗的患者，其治疗部位的癌症局部复发风险并未增加。
