Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive

Summary

This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy . Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

Timeline

Start

2019-02-18

Primary completion

2022-05-30

Completion

2026-03-08

Outcome

Missed primary endpoint

paper At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). PMID 39393844 ↗

Publications

• Pers YM, Soler-Rich R, Vadala G, Ferreira R, Duflos C, Picot MC, Herman F, Broussous S, Sanchez A, Noriega D, Ardura F, Alberca Zaballos M, Garcia V, Gordillo Cano V, Gonzalez-Vallinas M, Denaro V, Russo F, Guicheux J, Vilanova J, Orozco L, Meisel HJ, Alfonso M, Rannou F, Maugars Y, Berenbaum F, Barry FP, Tarte K, Louis-Plence P, Ferreira-Dos-Santos G, Garcia-Sancho J, Jorgensen C; RESPINE consortium. 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). Ann Rheum Dis. 2024 Oct 21;83(11):1572-1583. doi: 10.1136/ard-2024-225771.

Drugs

Indications