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Safety Study of Mesenchymal Stem Cells and Spinal Fusion

NCT01552707 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-01-21

No results posted yet for this study

Summary

The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.

Conditions

  • Lumbar Spondylolisthesis Involving L4-L5, and/or
  • Degenerative 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

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Joan Bagó, MD, PhD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-19
Primary Completion
2018-05-03
Completion
2019-10-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552707 on ClinicalTrials.gov