Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

Red de Terapia Celular15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intervertebral Disc Disease

Interventions

Instrumented posterolateral arthrodesisPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Trauma Service. Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Data from ClinicalTrials.gov

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