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Completed

NCT Number: NCT01513694

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

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).

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Key information

Conditions

Intervertebral Disc Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Trauma Service. Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Instrumented posterolateral arthrodesis

Procedure

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.

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
  • Spanish National Health System

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2012
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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