Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV) (Disc_allo)
Primary Purpose
Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Allogenic Mesenchymal Stromal Cells
Mepivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease,, Intervertebral Disc Disease, Low Back Pain, Nucleus pulposus, Stem cell, Cellular therapy, Regenerative therapy, Mesenchymal stem cells, Bone marrow, Musculoskeletal Diseases, Mesenchymal Stromal Cells (allogenic)
Eligibility Criteria
Inclusion Criteria:
- Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
- Fibrous ring capable of holding the cell implantation, demonstrated by RMI image (stages 2, 3 and 4 of Adams).
- Decrease of disc height of more than 20% (radiographic measurement in side image).
- Absence of spinal infection.
- Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
- The patient is able to understand the nature of the study.
- Informed written consent of the patient.
Exclusion Criteria:
- Age over 75 or under 18 or legally dependent
- Allergy to gentamicin, or to bovine, cattle or horse serum.
- Congenital or acquired diseases leading to spine deformations that may upset cell application.
- Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
- Modic III changes on MRI images (31).
- Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
- Pregnancy or breast-feeding
- Neoplasia
- Immunosuppression
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Other conditions that may, according to medical criteria, discourage participation in the study.
Sites / Locations
- Hospital Clinico Universitario
- Instituto de Biologia y Genetica Molecular
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Allogenic Mesenchymal Stromal Cells
Mepivacaine
Arm Description
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intradiscal injection of 25 millions MSC in 2 ml of saline
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
Outcomes
Primary Outcome Measures
Safety and tolerability
Number of participants with adverse events will be used as a measure of safety and tolerability. Adverse events reported: clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
Secondary Outcome Measures
Pain and disability evolution
Clinical review and questionaires (Visual Analogue Scales (VAS) and Oswestry questionnaires) at 0, 3, 6 and 12 months.
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI)
RMI density measurements in T2 weighted images performed at 0, 6 and 12 months used as an indication of disc fluid content
Llife quality evolution (Short Form (SF)-12 questionnaire)
SF-12 scores at 0, 3, 3 and 12 months
Full Information
NCT ID
NCT01860417
First Posted
May 18, 2013
Last Updated
April 25, 2017
Sponsor
Red de Terapia Celular
Collaborators
Citospin, University of Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT01860417
Brief Title
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
Acronym
Disc_allo
Official Title
Treatment of Lumbar Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Bone Marrow Mesenchymal Stromal Cells Expanded Using the Valladolid IBGM Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
Collaborators
Citospin, University of Valladolid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, PEI Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
Keywords
Degenerative Disc Disease,, Intervertebral Disc Disease, Low Back Pain, Nucleus pulposus, Stem cell, Cellular therapy, Regenerative therapy, Mesenchymal stem cells, Bone marrow, Musculoskeletal Diseases, Mesenchymal Stromal Cells (allogenic)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogenic Mesenchymal Stromal Cells
Arm Type
Experimental
Arm Description
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intradiscal injection of 25 millions MSC in 2 ml of saline
Arm Title
Mepivacaine
Arm Type
Active Comparator
Arm Description
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
Intervention Type
Biological
Intervention Name(s)
Allogenic Mesenchymal Stromal Cells
Other Intervention Name(s)
Mesenchymal stem cells (MSC), MSC injection, MSV (MSV=MSC prepared following Valladolid IBGM procedure)
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
Sham-treated comparator, Mepivacaine is also known as Carbocaine, Mepivacaine is also known as Polocaine
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Number of participants with adverse events will be used as a measure of safety and tolerability. Adverse events reported: clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Pain and disability evolution
Description
Clinical review and questionaires (Visual Analogue Scales (VAS) and Oswestry questionnaires) at 0, 3, 6 and 12 months.
Time Frame
up to 1 year
Title
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI)
Description
RMI density measurements in T2 weighted images performed at 0, 6 and 12 months used as an indication of disc fluid content
Time Frame
up to one year
Title
Llife quality evolution (Short Form (SF)-12 questionnaire)
Description
SF-12 scores at 0, 3, 3 and 12 months
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
Fibrous ring capable of holding the cell implantation, demonstrated by RMI image (stages 2, 3 and 4 of Adams).
Decrease of disc height of more than 20% (radiographic measurement in side image).
Absence of spinal infection.
Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
The patient is able to understand the nature of the study.
Informed written consent of the patient.
Exclusion Criteria:
Age over 75 or under 18 or legally dependent
Allergy to gentamicin, or to bovine, cattle or horse serum.
Congenital or acquired diseases leading to spine deformations that may upset cell application.
Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
Modic III changes on MRI images (31).
Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
Pregnancy or breast-feeding
Neoplasia
Immunosuppression
Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
Other conditions that may, according to medical criteria, discourage participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Garcia-Sancho, MD, PhD
Organizational Affiliation
Scientific Park Foundation of University of Valladolid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David C Noriega, MD, PhD
Organizational Affiliation
Hospital Clinico Universitario, Valladolid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Sanchez, MD, PhD
Organizational Affiliation
Citospin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
FRancisco Ardura, MD, PhD
Organizational Affiliation
Hospital Clinico Universitario, Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico Universitario
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Instituto de Biologia y Genetica Molecular
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21792091
Citation
Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.
Results Reference
background
PubMed Identifier
27661661
Citation
Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=orozco+and+garcia-sancho
Description
Treatment of Degenerative Disc Disease with Autologous Mesenchymal Stem Cells
URL
http://www.red-tercel.com
Description
Spanish Cell Therapy Network
URL
http://www.citospin.com
Description
Citospin S.L. (MSV Cell Production)
URL
http://www.ncbi.nlm.nih.gov/mesh/?term=intervertebral
Description
Intervertebral disk
URL
http://www.ncbi.nlm.nih.gov/mesh?term=cell%2C%20mesenchymal%20stem
Description
mesenchymal stem cells
Learn more about this trial
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
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