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

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01513694

Enrollment

Registered

2012-01-20

Start date

2010-01-31

Completion date

2017-05-04

Last updated

2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebral Disc Disease

Keywords

Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease

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).

Interventions

PROCEDUREInstrumented 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026