基于异基因骨髓间充质基质细胞的慢性腰背痛患者疗法:一项前瞻性、多中心、随机安慰剂对照试验(RESPINE 研究)。

IF 20.3 1区 医学 Q1 RHEUMATOLOGY Annals of the Rheumatic Diseases Pub Date : 2024-10-21 DOI:10.1136/ard-2024-225771
Yves-Marie Pers, Robert Soler-Rich, Gianluca Vadalà, Rosanna Ferreira, Claire Duflos, Marie-Christine Picot, Fanchon Herman, Sylvie Broussous, Ana Sánchez, David Noriega, Francisco Ardura, Mercedes Alberca Zaballos, Verónica García, Virginia Gordillo Cano, Margarita González-Vallinas, Vicenzo Denaro, Fabrizio Russo, Jérôme Guicheux, Joan Vilanova, Lluís Orozco, Hans-Jörg Meisel, Matias Alfonso, Francois Rannou, Yves Maugars, Francis Berenbaum, Frank P Barry, Karin Tarte, Pascale Louis-Plence, Guilherme Ferreira-Dos-Santos, Javier García-Sancho, Christian Jorgensen
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引用次数: 0

摘要

研究目的评估慢性腰背痛(LBP)患者一次椎间盘内注射异体骨髓间充质干细胞(BM-MSCs)与假安慰剂的疗效:在2018年4月至2022年12月期间,参与者在一项前瞻性双盲对照研究中随机接受假注射或2000万异体骨髓间充质干细胞椎间盘内注射。第一个共同主要终点是基线至第12个月期间,疼痛视觉模拟量表(VAS)改善至少20%和20毫米,或奥斯韦特里残疾指数(ODI)改善20%的应答者比率。次要结构性共同主要终点通过定量核磁共振成像 T2 测量基线至第 12 个月期间的椎间盘液含量来评估。次要终点包括疼痛 VAS、ODI、简表 (SF)-36 和所有时间点(1、3、6、12 和 24 个月)的最小临床重要差异。我们确定了基线至 6 个月期间与异体细胞注射相关的免疫反应。我们还记录了严重不良事件(SAE):114名患者被随机分组(58人,BM-间充质干细胞组;56人,假安慰剂组)。12个月后,主要结果未达到(BM-间充质干细胞组为74%,安慰剂组为69%;P=0.77)。两组在所有次要结果上没有差异。没有发生与干预相关的 SAE:结论:虽然我们的研究并未最终证明异体间充质干细胞治疗枸杞多糖症的疗效,但该疗法是安全的。间充质干细胞治疗枸杞多糖症的长期疗效仍在研究中:EudraCT 2017-002092-25/ClinicalTrials.gov:NCT03737461。
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Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study).

Objectives: To assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).

Methods: Participants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded.

Results: 114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred.

Conclusions: While our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied.

Trial registration number: EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.

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来源期刊
Annals of the Rheumatic Diseases
Annals of the Rheumatic Diseases 医学-风湿病学
CiteScore
35.00
自引率
9.90%
发文量
3728
审稿时长
1.4 months
期刊介绍: Annals of the Rheumatic Diseases (ARD) is an international peer-reviewed journal covering all aspects of rheumatology, which includes the full spectrum of musculoskeletal conditions, arthritic disease, and connective tissue disorders. ARD publishes basic, clinical, and translational scientific research, including the most important recommendations for the management of various conditions.
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