Overview

This trial is active, not recruiting.

Condition intervertebral disc disease
Treatment instrumented posterolateral arthrodesis
Phase phase 1/phase 2
Sponsor Red de Terapia Celular
Collaborator Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Start date January 2010
Trial size 15 participants
Trial identifier NCT01513694, CSM/Fusión/2009

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
instrumented posterolateral arthrodesis
Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: Clinical - 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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Red de Terapia Celular.