Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
Primary Purpose
Intervertebral Disc Disease
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Instrumented posterolateral arthrodesis
Sponsored by
About this trial
This is an interventional treatment trial for Intervertebral Disc Disease focused on measuring Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease
Eligibility 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.
Sites / Locations
- Trauma Service. Hospital Universitario de Salamanca
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MSC seeded onto a phosphate ceramic
Arm Description
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01513694
First Posted
January 16, 2012
Last Updated
June 1, 2017
Sponsor
Red de Terapia Celular
Collaborators
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
1. Study Identification
Unique Protocol Identification Number
NCT01513694
Brief Title
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 4, 2017 (Actual)
Study Completion Date
May 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
Collaborators
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Disease
Keywords
Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSC seeded onto a phosphate ceramic
Arm Type
Experimental
Arm Description
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
Intervention Type
Procedure
Intervention Name(s)
Instrumented posterolateral arthrodesis
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Trauma Service. Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castilla-León
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30795797
Citation
Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.
Results Reference
derived
Links:
URL
http://www.red-tercel.com
Description
Spanish cell therapy network (TerCel)
URL
http://fundacion.usal.es
Description
Salamanca University Foundation
URL
http://www.isciii.es
Description
Spanish Health Institute Carlos III
Learn more about this trial
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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