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