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.

Conditions

• Recurrent Low Back Pain
• Degenerative Disc Disease (DDD)

Interventions

DRUG

Allogenic BM-MSCs Injection

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

OTHER

Sham Procedure

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.

Sponsors & Collaborators

• Interdisziplinäres Zentrum Klinische Studien (IZKS)

  collaborator UNKNOWN

• European Clinical Research Infrastructure Network

  collaborator OTHER

• Département de l'information médicale, CHU de Montpellier

  collaborator UNKNOWN

• Centre National de la Recherche Scientifique, France

  collaborator OTHER

• Université Montpellier

  collaborator OTHER

• Univercell-Biosolutions S.A.S

  collaborator UNKNOWN

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• University of Valladolid

  collaborator OTHER

• Citospin

  collaborator INDUSTRY

• Rennes University Hospital

  collaborator OTHER

• APHP

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• BG Klinikum Bergmannstrost, Halle, Germany

  collaborator UNKNOWN

• Nantes University Hospital

  collaborator OTHER

• Institut de Terapia Regenerativa Tissular

  collaborator OTHER

• University of Navarra

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Christian CJ JORGENSEN, PhD · Montpellier University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-18

Primary Completion

2022-05-30

Completion

2026-03-08

Countries

• France
• Germany
• Italy
• Spain

Study Locations