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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

February 18, 2019

Primary Completion Date

May 30, 2022

Study Completion Date

March 8, 2026

Conditions
Recurrent Low Back PainDegenerative 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.

Trial Locations (9)

31008

Clínica Universidad de Navarra, Pamplona

34295

UH Montpellier, Montpellier

47002

Hospital Sagrado Corazón Valladolid, Valladolid

75012

CHU Saint Antoine, Paris

Unknown

CHU de Nantes, Nantes

APHP Cochin, Paris

06112

BG Klinikum Bergmannstrost, Halle

00128

Campus Bio-Medico University of Rome, Roma

08022

Institut de Teràpia Regenerativa Tissular, Barcelona

All Listed Sponsors
collaborator

Interdisziplinäres Zentrum Klinische Studien (IZKS)

UNKNOWN

collaborator

European Clinical Research Infrastructure Network

OTHER

collaborator

Département de l'information médicale, CHU de Montpellier

UNKNOWN

collaborator

Centre National de la Recherche Scientifique, France

OTHER

collaborator

Université Montpellier

OTHER

collaborator

Univercell-Biosolutions S.A.S

UNKNOWN

collaborator

National University of Ireland, Galway, Ireland

OTHER

collaborator

University of Valladolid

OTHER

collaborator

Citospin

INDUSTRY

collaborator

Rennes University Hospital

OTHER

collaborator

APHP

OTHER

collaborator

Campus Bio-Medico University

OTHER

collaborator

BG Klinikum Bergmannstrost, Halle, Germany

UNKNOWN

collaborator

Nantes University Hospital

OTHER

collaborator

Institut de Terapia Regenerativa Tissular

OTHER

collaborator

University of Navarra

OTHER

lead

University Hospital, Montpellier

OTHER