Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
Conditions
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)
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, 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).
Interventions
BIOLOGICALAllogenic Mesenchymal Stromal Cells
DRUGMepivacaine
Sponsors
Citospin
University of Valladolid
Red de Terapia Celular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 Magnetic resonance imaging (MRI) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and Disability Evaluation | Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months | At 6 months after the intervention | 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. |
| Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months | At 12 months after the intervention | 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. |
| Visual Analogue Scale at 3 Months | At 3 months after the intervention | 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 |
| Visual Analogue Scale at 6 Months | At 6 months after the intervention | 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 |
| Visual Analogue Scale at 12 Months | At 12 months after the intervention | 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 |
| Oswestry Disability Index at 3 Months | At 3 months after the intervention | 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 |
| Oswestry Disability Index at 6 Months | At 6 months after the intervention | 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 |
| Oswestry Disability Index at 12 Months | At 12 months after the intervention | 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 |
| Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months | At 12 months from 6 months after the intervention | 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. |
| SF-12 Physical Component at 6 Months | 6 months after the intervention | 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 |
| SF-12 Physical Component at 12 Months | 12 months after the intervention | 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 |
| SF-12 Mental Component at 3 Months | 3 months after the intervention | 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 |
| SF-12 Mental Component at 6 Months | 6 months after the intervention | 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 |
| SF-12 Mental Component at 12 Months | 12 months after the intervention | 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 |
| Pfirrmann Stage at 6 Months | At 6 months after the intervention | 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 |
| Pfirrmann Stage at 12 Months | At 12 months after the intervention | 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 |
| SF-12 Physical Component at 3 Months | 3 months after the intervention | 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 |
Countries
Spain
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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). | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Allogenic Mesenchymal Stromal Cells | Mepivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 40.5 years | 37 years | 38 years |
| Body mass index | 25.5 kg/m^2 | 24.0 kg/m^2 | 24.5 kg/m^2 |
| Height | 166.5 cm | 176.5 cm | 172 cm |
| Oswestry Disability Index | 26 units on a scale | 22 units on a scale | 24 units on a scale |
| Participants with Previous Treatment | 11 Participants | 12 Participants | 23 Participants |
| Pfirrmann grading system Gr II | 0 Participants | 3 Participants | 3 Participants |
| Pfirrmann grading system Gr III | 5 Participants | 8 Participants | 13 Participants |
| Pfirrmann grading system Gr IV | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment Spain | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
| SF-12 Mental Component | 50 units on a scale | 50 units on a scale | 50 units on a scale |
| SF-12 Physical Component | 38 units on a scale | 42.5 units on a scale | 38.5 units on a scale |
| Visual Analogue Scale | 73.5 units on a scale | 72.5 units on a scale | 73 units on a scale |
| Weight | 72 Kg | 74 Kg | 72.5 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 5 / 12 | 9 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
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.
Time frame: Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Pain and Disability Evaluation | 0.28 scores from 0 to 1 | Standard Error 0.07 |
| Mepivacaine | Pain and Disability Evaluation | 0.15 scores from 0 to 1 | Standard Error 0.1 |
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.
Time frame: At 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months | 0.52 ratio | Standard Error 0.06 |
| Mepivacaine | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months | 0.46 ratio | Standard Error 0.05 |
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.
Time frame: At 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months | 0.42 ratio | Standard Error 0.05 |
| Mepivacaine | Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months | 0.51 ratio | Standard Error 0.05 |
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.
Time frame: At 12 months from 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months | 0.22 ratio | Standard Error 0.11 |
| Mepivacaine | Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months | 0.06 ratio | Standard Error 0.08 |
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
Time frame: At 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Oswestry Disability Index at 12 Months | 22 percent | Standard Error 7 |
| Mepivacaine | Oswestry Disability Index at 12 Months | 34 percent | Standard Error 7 |
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
Time frame: At 3 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Oswestry Disability Index at 3 Months | 16 percent | Standard Error 6 |
| Mepivacaine | Oswestry Disability Index at 3 Months | 25 percent | Standard Error 4 |
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
Time frame: At 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Oswestry Disability Index at 6 Months | 20 percent | Standard Error 7 |
| Mepivacaine | Oswestry Disability Index at 6 Months | 30 percent | Standard Error 6 |
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
Time frame: At 12 months after the intervention
Population: One patient not evaluated
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 12 Months | Gr II | 1 Participants |
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 12 Months | Gr III | 9 Participants |
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 12 Months | Gr IV | 1 Participants |
| Mepivacaine | Pfirrmann Stage at 12 Months | Gr II | 1 Participants |
| Mepivacaine | Pfirrmann Stage at 12 Months | Gr III | 4 Participants |
| Mepivacaine | Pfirrmann Stage at 12 Months | Gr IV | 7 Participants |
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
Time frame: At 6 months after the intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 6 Months | Gr II | 0 Participants |
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 6 Months | Gr III | 10 Participants |
| Allogenic Mesenchymal Stromal Cells | Pfirrmann Stage at 6 Months | Gr IV | 2 Participants |
| Mepivacaine | Pfirrmann Stage at 6 Months | Gr II | 1 Participants |
| Mepivacaine | Pfirrmann Stage at 6 Months | Gr III | 8 Participants |
| Mepivacaine | Pfirrmann Stage at 6 Months | Gr IV | 3 Participants |
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
Time frame: 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Mental Component at 12 Months | 48 units on a scale | Standard Error 3 |
| Mepivacaine | SF-12 Mental Component at 12 Months | 50 units on a scale | Standard Error 3 |
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
Time frame: 3 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Mental Component at 3 Months | 50 units on a scale | Standard Error 2 |
| Mepivacaine | SF-12 Mental Component at 3 Months | 46 units on a scale | Standard Error 3 |
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
Time frame: 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Mental Component at 6 Months | 52 units on a scale | Standard Error 2 |
| Mepivacaine | SF-12 Mental Component at 6 Months | 48 units on a scale | Standard Error 3 |
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
Time frame: 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Physical Component at 12 Months | 45 units on a scale | Standard Error 3 |
| Mepivacaine | SF-12 Physical Component at 12 Months | 42 units on a scale | Standard Error 3 |
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
Time frame: 3 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Physical Component at 3 Months | 47 units on a scale | Standard Error 3 |
| Mepivacaine | SF-12 Physical Component at 3 Months | 43 units on a scale | Standard Error 3 |
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
Time frame: 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | SF-12 Physical Component at 6 Months | 46 units on a scale | Standard Error 3 |
| Mepivacaine | SF-12 Physical Component at 6 Months | 39 units on a scale | Standard Error 3 |
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
Time frame: At 12 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Visual Analogue Scale at 12 Months | 47 units on a scale | Standard Error 10 |
| Mepivacaine | Visual Analogue Scale at 12 Months | 47 units on a scale | Standard Error 8 |
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
Time frame: At 3 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Visual Analogue Scale at 3 Months | 43 units on a scale | Standard Error 9 |
| Mepivacaine | Visual Analogue Scale at 3 Months | 46 units on a scale | Standard Error 8 |
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
Time frame: At 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allogenic Mesenchymal Stromal Cells | Visual Analogue Scale at 6 Months | 40 units on a scale | Standard Error 8 |
| Mepivacaine | Visual Analogue Scale at 6 Months | 51 units on a scale | Standard Error 8 |