Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.

Red de Terapia Celular1 site in 1 country15 target enrollmentJanuary 2010

ConditionsIntervertebral Disc Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Intervertebral Disc Disease
Sponsor: Red de Terapia Celular
Enrollment: 15
Locations: 1
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

May 4, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Red de Terapia Celular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
•Discopathy refractory to conservative treatment (drugs, physical therapy.)
•Evolution greater than or equal to 6 months. Radiological
•Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
•NMR: grades IV and V of Pfirman.

Exclusion Criteria

•Rejection of surgical treatment.
•Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
•Immunosuppressive treatment.
•Congenital or acquired anatomical abnormality that prevents the surgical procedure.
•Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
•High surgical risk (ASA\> IV), or contraindication to anesthesia.