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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

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ClinicalTrials.gov Identifier: NCT01513694
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : June 2, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Intervertebral Disc Disease Procedure: Instrumented posterolateral arthrodesis Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2010
Primary Completion Date : May 4, 2017
Study Completion Date : May 4, 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.



Outcome Measures

Eligibility Criteria

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513694


Locations
Spain
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
ClinicalTrials.gov Identifier: NCT01513694     History of Changes
Other Study ID Numbers: CSM/Fusión/2009
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017

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
Hernia
Pathological Conditions, Anatomical