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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01513694
First received: January 16, 2012
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Spanish cell therapy network (TerCel)  This link exits the ClinicalTrials.gov site
Salamanca University Foundation  This link exits the ClinicalTrials.gov site
Spanish Health Institute Carlos III  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01513694     History of Changes
Other Study ID Numbers: CSM/Fusión/2009
Study First Received: January 16, 2012
Last Updated: October 19, 2012
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health

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

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Bone Diseases
 Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013