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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004444-30 | EudraCT Number | ||
| Disc_allo_MSV | Other Identifier | Red TerCel |
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| Name | Class |
|---|---|
| Citospin | INDUSTRY |
| University of Valladolid | OTHER |
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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, Investigational medicinal product 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Experimental | 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 |
|
| Mepivacaine | Active Comparator | Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Disability Evaluation | Change in the composite variable, which includes pain and disability 1 year after intervention, was plotted as a function of the initial pain score or disability index. Results for the relief of lumbar pain and Oswestry disability index were all included for both, control and cell-treated patients. The scores obtained from this analysis (slope of the plot) range from 0 to 1, with higher scores meaning a better outcome. | Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months | Ratio discs density: Discs density at 12 months divided by discs density at 6 months after transplantation. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Garcia-Sancho, MD, PhD | Scientific Park Foundation of University of Valladolid | Study Chair |
| David C Noriega, MD, PhD | Hospital Clinico Universitario, Valladolid | Study Director |
| Ana Sanchez, MD, PhD | Citospin | Study Director |
| FRancisco Ardura, MD, PhD | Hospital Clinico Universitario, Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario | Valladolid | 47003 | Spain | |||
| Instituto de Biologia y Genetica Molecular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21792091 | Background | 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. | |
| 27661661 | Derived | 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. |
| Label | URL |
|---|---|
| Treatment of Degenerative Disc Disease with Autologous Mesenchymal Stem Cells | View source |
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Recruitment was performed between June 2013 and March 2014. Date of Last visit last patient was December 2015. The study was conducted in only one center in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Allogenic Bone Marrow Mesenquimal Cells | 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 |
| FG001 | Mepivacaine | Infiltration of paravertebral musculature close to the affected disc(s). The control group received a sham infiltration of paravertebral musculature with the anesthetic: saline containing 1% mepivacaine (1 ml of 2% mepivacaine + 1 ml of saline). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allogenic Mesenchymal Stromal Cells | 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 |
| BG001 | Mepivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain and Disability Evaluation | Change in the composite variable, which includes pain and disability 1 year after intervention, was plotted as a function of the initial pain score or disability index. Results for the relief of lumbar pain and Oswestry disability index were all included for both, control and cell-treated patients. The scores obtained from this analysis (slope of the plot) range from 0 to 1, with higher scores meaning a better outcome. | Posted | Mean | Standard Error | scores from 0 to 1 | Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention |
|
Adverse events reporting started when after the administration of the study treatments, and lasted up to the last visit of each patient at the end of the follow-up period, 12 months after the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allogenic Mesenchymal Stromal Cells | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device failure | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
Further studies shall track the long-term evolution as well as investigate the anatomical and functional changes that occur in the intervertebral spaces and shall increase the number of patients, which was an important limitation of the present study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Javier García-Sancho, | CITOSPIN | 0034 983184827 | jgsancho@uva.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 3, 2012 | Nov 29, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| C535531 | Intervertebral disc disease |
| D017116 | Low Back Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 |
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| ID | Term |
|---|---|
| D016258 | Genes, mos |
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D011519 | Proto-Oncogenes |
| D009857 | Oncogenes |
| D052138 | Genes, Neoplasm |
| D005796 | Genes |
| D040481 |
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| Mepivacaine | Drug |
|
|
| At 12 months from 6 months after the intervention |
| Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months | Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. | At 6 months after the intervention |
| Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months | Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. | At 12 months after the intervention |
| Visual Analogue Scale at 3 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | At 3 months after the intervention |
| Visual Analogue Scale at 6 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | At 6 months after the intervention |
| Visual Analogue Scale at 12 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | At 12 months after the intervention |
| Oswestry Disability Index at 3 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | At 3 months after the intervention |
| Oswestry Disability Index at 6 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | At 6 months after the intervention |
| Oswestry Disability Index at 12 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | At 12 months after the intervention |
| SF-12 Physical Component at 3 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 3 months after the intervention |
| SF-12 Physical Component at 6 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 6 months after the intervention |
| SF-12 Physical Component at 12 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 12 months after the intervention |
| SF-12 Mental Component at 3 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 3 months after the intervention |
| SF-12 Mental Component at 6 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 6 months after the intervention |
| SF-12 Mental Component at 12 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | 12 months after the intervention |
| Pfirrmann Stage at 6 Months | Grades: Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased. Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed | At 6 months after the intervention |
| Pfirrmann Stage at 12 Months | Grades: Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased. Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed | At 12 months after the intervention |
| Valladolid |
| 47003 |
| Spain |
| Citospin S.L. (MSV Cell Production) | View source |
| Instituto de Biologia y Genética Molecular IBGM), Cell Production Research | View source |
| Intervertebral disk | View source |
| mesenchymal stem cells | View source |
Infiltration of paravertebral musculature close to the affected disc(s). The control group received a sham infiltration of paravertebral musculature with the anesthetic: saline containing 1% mepivacaine (1 ml of 2% mepivacaine + 1 ml of saline).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Median | Full Range | Kg |
|
| Height | Median | Full Range | cm |
|
| Body mass index | Median | Full Range | kg/m^2 |
|
| Participants with Previous Treatment | Count of Participants | Participants |
|
| Visual Analogue Scale | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | Median | Full Range | units on a scale |
|
| Oswestry Disability Index | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | Median | Full Range | units on a scale |
|
| SF-12 Physical Component | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Median | Full Range | units on a scale |
|
| SF-12 Mental Component | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Median | Full Range | units on a scale |
|
| Pfirrmann grading system | Grades:
| Count of Participants | Participants |
|
| Mepivacaine |
Infiltration of paravertebral musculature close to the affected disc(s). The control group received a sham infiltration of paravertebral musculature with the anesthetic: saline containing 1% mepivacaine (1 ml of 2% mepivacaine + 1 ml of saline). |
|
|
| Secondary | Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months | Ratio discs density: Discs density at 12 months divided by discs density at 6 months after transplantation. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. | Posted | Mean | Standard Error | ratio | At 12 months from 6 months after the intervention |
|
|
|
| Secondary | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months | Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. | Posted | Mean | Standard Error | ratio | At 6 months after the intervention |
|
|
|
| Secondary | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months | Measurement of the amount of fluid in the disc. To homogenize the results of different patients, the water content values of the affected discs were normalized to the values obtained from the healthy discs in the same individual; for these purposes, the density of the affected segments was divided by the average value of the healthy discs. Finally, the value after the treatment was divided by the baseline value. | Posted | Mean | Standard Error | ratio | At 12 months after the intervention |
|
|
|
| Secondary | Visual Analogue Scale at 3 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | Posted | Mean | Standard Error | units on a scale | At 3 months after the intervention |
|
|
|
| Secondary | Visual Analogue Scale at 6 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | Posted | Mean | Standard Error | units on a scale | At 6 months after the intervention |
|
|
|
| Secondary | Visual Analogue Scale at 12 Months | Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% scale. A higher score indicates greater pain intensity | Posted | Mean | Standard Error | units on a scale | At 12 months after the intervention |
|
|
|
| Secondary | Oswestry Disability Index at 3 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | Posted | Mean | Standard Error | percent | At 3 months after the intervention |
|
|
|
| Secondary | Oswestry Disability Index at 6 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | Posted | Mean | Standard Error | percent | At 6 months after the intervention |
|
|
|
| Secondary | Oswestry Disability Index at 12 Months | Subject's Disability score in the Oswestry Disability Index (ODI) before intervention. Outcomes are expressed using a 0%-100% scale. Zero is equated with no disability and 100 is the maximum disability possible | Posted | Mean | Standard Error | percent | At 12 months after the intervention |
|
|
|
| Secondary | SF-12 Physical Component at 3 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 3 months after the intervention |
|
|
|
| Secondary | SF-12 Physical Component at 6 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention |
|
|
|
| Secondary | SF-12 Physical Component at 12 Months | Results from the physical component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 12 months after the intervention |
|
|
|
| Secondary | SF-12 Mental Component at 3 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 3 months after the intervention |
|
|
|
| Secondary | SF-12 Mental Component at 6 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 6 months after the intervention |
|
|
|
| Secondary | SF-12 Mental Component at 12 Months | Results from the mental component of the short form-12 (SF-12) life quality questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning | Posted | Mean | Standard Error | units on a scale | 12 months after the intervention |
|
|
|
| Secondary | Pfirrmann Stage at 6 Months | Grades: Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased. Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed | Posted | Count of Participants | Participants | At 6 months after the intervention |
|
|
|
| Secondary | Pfirrmann Stage at 12 Months | Grades: Gr I: Disc homogeneous. Bight hyperintense white signal intensity. Normal height Gr II: Disc inhomogeneous. Hyperintense white signal. Nucleus/annulus clearly differentiated. Height is normal Gr III: Disc inhomogeneous. Intermittent gray signal intensity. Unclear distinction nucleus/annulus. Height normal/slightly decreased Gr IV: Disc inhomogeneous. Hypointense dark gray signal intensity. No distinction nucleus/annulus. Height slightly/moderately decreased. Gr V: Disc inhomogeneous. Hypointense black signal intensity. No distinction nucleus/annulus. Disc space is collapsed | One patient not evaluated | Posted | Count of Participants | Participants | At 12 months after the intervention |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 5 |
| 12 |
| EG001 | Mepivacaine | Infiltration of paravertebral musculature close to the affected disc(s). The control group received a sham infiltration of paravertebral musculature with the anesthetic: saline containing 1% mepivacaine (1 ml of 2% mepivacaine + 1 ml of saline). | 0 | 12 | 0 | 12 | 9 | 12 |
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| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Gr IV |
|
| Gr IV |
|