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

Study acronym: RESPINE
StatusActive, Not Recruiting
PhasePhase 2/3
Started2019-02-18
View on ClinicalTrials.gov ↗

Amendment history

2025-09-24
Study Identification, Study Status, Oversight, IPDSharing v6
Re-verified, no change to tracked fields
2023-08-11
Study Status, Contacts/Locations v5
Completion date2023-04→2026-03-08
Study sites3→9
2022-07-08
Study Status v4
Primary completion dateestimated 2022-04→confirmed 2022-05-30
2021-12-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2021-12→2022-04
Completion date2022-12→2023-04
Enrollment targetestimated 112→confirmed 113
Study sitesdetails revised at 3 of 3 sites
2020-04-09
Study Status v2
Primary completion date2020-12→2021-12
Completion date2020-12→2022-12
2019-05-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-12→confirmed 2019-02-18
Study sites0→3
2018-11-08
Original filing
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.
Trial Details
NCT Number NCT03737461
Lead Sponsor University Hospital, Montpellier
Collaborators: Interdisziplinäres Zentrum Klinische Studien (IZKS), European Clinical Research Infrastructure Network, Département de l'information médicale, CHU de Montpellier, Centre National de la Recherche Scientifique, France, Université Montpellier, Univercell-Biosolutions S.A.S, National University of Ireland, Galway, Ireland, University of Valladolid, Citospin, Rennes University Hospital, APHP, Campus Bio-Medico University, BG Klinikum Bergmannstrost, Halle, Germany, Nantes University Hospital, Institut de Terapia Regenerativa Tissular, University of Navarra
Conditions Recurrent Low Back Pain, Degenerative Disc Disease (DDD)
Enrollment 113 participants
Start Date 2019-02-18
Primary Completion 2022-05-30 (estimated)
Study Completion 2026-03-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-30