NCT01552707 - Safety Study of Mesenchymal Stem Cells and Spinal Fusion | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 19, 2012

Primary Completion Date

May 3, 2018

Study Completion Date

October 21, 2019

Conditions

Lumbar Spondylolisthesis Involving L4-L5, and/orDegenerative Discopathy Involving L4-L5

Interventions

BIOLOGICAL

XCEL-MT-OSTEO-ALPHA

"Isolation and ex-vivo expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion."

PROCEDURE

Standard treatment

Instrumented spinal fusion together with patient's bone iliac crest

Trial Locations (5)

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08003

Parc de Salut Mar, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08028

Institut Universitari Dexeus (ICATME), Barcelona

08035

Hospital Vall d'Hebron, Barcelona

All Listed Sponsors

collaborator

TFS Trial Form Support

INDUSTRY

collaborator

Ministerio de Sanidad, Servicios Sociales e Igualdad

OTHER_GOV

collaborator

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

lead

Banc de Sang i Teixits

OTHER