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

June 1, 2017 updated by: Red de Terapia Celular

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla-León
      • Salamanca, Castilla-León, Spain, 37007
        • Trauma Service. Hospital Universitario de Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red de Terapia Celular

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 4, 2017

Study Completion (Actual)

May 4, 2017

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSM/Fusión/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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