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

NCT03737461 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: RECHMPL17_02062017-002092-25
• Study Type: interventional
• Target: 113
• Locations: 4 countries
• Sites: 9

Brief 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.

Conditions

Recurrent Low Back Pain; Degenerative Disc Disease (DDD)

Keywords

BM-MSCs; Low back pain; Lumbar degenerative disc disease (DDD)

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Pain Clinical response at 12 months

  The clinical response is defined as the Pain relief measure with Visual Analogue Scale (VAS) of at least 20 mm decrease on VAS scale between baseline and month 12.

  baseline to month 12

• Change from Baseline Oswestry Disability Index (ODI) measure at 12 months

  at least 20% improvement of functional index ODI at month 12 compared to baseline.

  baseline to month 12

Secondary Outcomes (9)

• Measure disability and quality of life evolution of the patient

  Baseline, 3,6,12 and 24 months

• Disability and quality of life evolution

  baseline, 3,6,12 and 24 months

• Pain killers

  baseline, 1, 3,6,12 and 24 months

• Measure of the Chronic low back pain

  baseline, 1, 3,6,12 and 24 months

• Employment and work status

  baseline, 1, 3,6,12 and 24 months

Study Arms (2)

Allogenic BM-MSCs Injection

EXPERIMENTAL

Injection of a dose of 20.106 allogenic BM-MSCs via imaging control into the disk affected by DDD where they are expected to exert their therapeutic effects.

Drug: Allogenic BM-MSCs Injection

Sham Procedure

SHAM COMPARATOR

anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment

Other: Sham Procedure

Interventions

Allogenic BM-MSCs Injection DRUG

Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution

Allogenic BM-MSCs Injection

Sham Procedure OTHER

sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment.

Also known as: Injection of 2 mL of 1% xylocaine

Sham Procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• DDD assessed by (Pfirrmann's score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann's score 1-4 maximum)
• Low back Pain baseline \> 40 mm on VAS (0-100).
• NSAID washout of at least 2 days before screening
• Painkillers washout of at least 24 hours before screening

You may not qualify if:

• Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization).
• Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy).
• Prior to the screening visit, has received:
• Oral corticosteroid therapy within the previous 3 months, OR
• Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months
• Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation \> 3 mm and/or angular mobility \> 15°).
• Spinal canal stenosis (Schizas score \> B).
• History of spinal infection.
• Lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar cysts and radiculopathy
• Previous discal puncture or previous spine surgery.
• DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
• Patients not eligible to the intravertebral disc surgery
• Patients who have the risk to undergo a surgery in the next 6 months
• Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
• Abnormal blood tests: hepatic (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 × upper limit of normal (ULN)), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of \<100 × 109/

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Interdisziplinäres Zentrum Klinische Studien (IZKS): collaborator
• European Clinical Research Infrastructure Network: collaborator
• Département de l'information médicale, CHU de Montpellier: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• Université Montpellier: collaborator
• Univercell-Biosolutions S.A.S: collaborator
• National University of Ireland, Galway, Ireland: collaborator
• University of Valladolid: collaborator
• Citospin: collaborator
• Rennes University Hospital: collaborator
• APHP: collaborator
• Campus Bio-Medico University: collaborator
• BG Klinikum Bergmannstrost, Halle, Germany: collaborator
• Nantes University Hospital: collaborator
• Institut de Terapia Regenerativa Tissular: collaborator
• University of Navarra: collaborator

Study Sites (9)

UH Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, France

Location

CHU Saint Antoine

Paris, 75012, France

Location

APHP Cochin

Paris, France

Location

BG Klinikum Bergmannstrost

Halle, 06112, Germany

Location

Campus Bio-Medico University of Rome

Roma, 00128, Italy

Location

Institut de Teràpia Regenerativa Tissular

Barcelona, 08022, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Sagrado Corazón Valladolid

Valladolid, 47002, Spain

Location

Related Publications (1)

• 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.

  PMID: 39393844 DERIVED

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christian CJ JORGENSEN, PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: November 9, 2018
• Study Start: February 18, 2019
• Primary Completion: May 30, 2022
• Study Completion: March 8, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (3); FR (4); IT (1)