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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Red de Terapia Celular.
Recruitment status was:  Active, not recruiting
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular Identifier:
First received: January 16, 2012
Last updated: October 19, 2012
Last verified: October 2012
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).

Condition Intervention Phase
Intervertebral Disc Disease
Procedure: Instrumented posterolateral arthrodesis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Red de Terapia Celular:

Estimated Enrollment: 15
Study Start Date: January 2010
Arms Assigned Interventions
Experimental: MSC seeded onto a phosphate ceramic
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
Procedure: 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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01513694

Trauma Service. Hospital Universitario de Salamanca
Salamanca, Castilla-León, Spain, 37007
Sponsors and Collaborators
Red de Terapia Celular
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
  More Information

Additional Information:
Responsible Party: Red de Terapia Celular Identifier: NCT01513694     History of Changes
Other Study ID Numbers: CSM/Fusión/2009
Study First Received: January 16, 2012
Last Updated: October 19, 2012

Keywords provided by Red de Terapia Celular:
Mesenchymal Stem Cells
Stem Cells
Intervertebral disc disease

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical processed this record on April 28, 2017