Center for Advanced Spine Care of Southern Arizona and Surgical Institute of Tucson, Tucson AZ, USA; Department of Orthopedics, Fundación Universitaria Sanitas, Bogotá, D.C., Colombia; Department of Neurosurgery in the Video-Endoscopic Postgraduate Program at the Universidade Federal do Estado do Rio de Janeiro - UNIRIO, Brazil.
Endoscopic Spine Clinic, Santiago, Chile; Department of Orthopedic Surgery, USP, Ribeirão Preto, Brazil.
Pain Physician. 2023 Mar;26(2):197-206.
Treatment of intermediate-stage painful degenerative disc disease is controversial, with few reliable options. Allogenic mesenchymal stem cells (MSCs)are an alternative to autologous stem cell transplantation. Allogeneic MSCs in the treatment of discogenic low back pain have some practical advantages, ranging from availability to ease of treatment in a procedure-room setting.
To assess the efficacy and safety of allogenic MSC injection into painful lumbar intervertebral discs and associated clinical outcomes.
Retrospective observational cohort study.
Private practice.
There were 33 patients: 15 women and 18 men with an average age of 47.6 years. The patients' average follow-up was 26.88 months Patients were treated with intradiscal injection of approximately 5 million allogeneic polyclonal MSCs in 1% hyaluronic acid derived from immunoselected umbilical cord stem cells. Patients were monitored for adverse event reactions. Clinical outcomes were assessed with reductions in the reported Visual Analog Scale (VAS) for back pain, the Oswestry Disability Index (ODI) scores, and the use of the modified Macnab criteria.
No patient required any additional treatments for low back pain stemming from the level treated with MSC injections. At a 2-year follow-up, the average VAS low back score reduction was 6.565 ± 1.619 and 38.333 ± 14.865 for the ODI (P < 0.001). Reported Macnab outcomes were excellent in 11 patients (33.3%), good in 19 (57.6%), and fair in 3 (9.1%).
Our observational study is limited by patient selection, hindsight bias, and low patient numbers.
The results of our feasibility study suggest that the injection of allogeneic MSCs to treat patients with painful intermediate-stage degenerative disc disease has merit. No adverse reactions were observed. The authors recommend further study in a randomized prospective study setting with a placebo control group or a natural history study group of patients to solidify this research.
治疗中期疼痛性退行性椎间盘疾病存在争议，可靠的选择方法有限。同种异体间充质干细胞（MSCs）是自体干细胞移植的一种替代方法。同种异体 MSCs 治疗椎间盘源性腰痛具有一些实际优势，从可用性到在治疗室环境中治疗的简便性。
评估向疼痛性腰椎间盘内注射同种异体 MSC 的疗效和安全性及相关临床结果。
回顾性观察队列研究。
私人诊所。
共有 33 名患者：15 名女性和 18 名男性，平均年龄为 47.6 岁。患者平均随访 26.88 个月。患者接受了约 500 万个同种异体多克隆 MSC 的椎间盘内注射，这些 MSC 悬浮于免疫选择的脐带干细胞衍生的 1%透明质酸中。监测患者的不良反应。通过视觉模拟量表（VAS）腰痛评分、Oswestry 功能障碍指数（ODI）评分和改良 Macnab 标准的使用来评估临床结果。
没有患者因 MSC 注射治疗的水平而需要任何额外的腰痛治疗。在 2 年的随访中，平均 VAS 腰痛评分降低了 6.565 ± 1.619，ODI 降低了 38.333 ± 14.865（P < 0.001）。11 例（33.3%）患者的 Macnab 结果为优秀，19 例（57.6%）为良好，3 例（9.1%）为一般。
我们的观察性研究受到患者选择、后见之明偏差和患者数量低的限制。
我们的可行性研究结果表明，向患有疼痛性中期退行性椎间盘疾病的患者注射同种异体 MSCs 具有一定的价值。未观察到不良反应。作者建议在随机前瞻性研究中进一步研究，设立安慰剂对照组或自然病史研究组患者，以巩固这一研究。
