Clinical Trial Results:
Treatment of degenerative disc disease with allogenic mesenchymal cells—MSV (Mesenchymal stromal cells (MSCs) extracted from the bone marrow and expanded "in vivo" following the GMP procedures developed by the institute of biology and molecular genetics from Valladolid).
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Summary
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EudraCT number |
2012-004444-30 |
Trial protocol |
ES |
Global end of trial date |
15 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jun 2021
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First version publication date |
20 Jun 2021
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Other versions |
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Summary report(s) |
Intervertebral disc repair by allogeneic mesenchymal bone marrow cells: a randomized controlled trial Supplementary data |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Disc_allo_MSV
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01860417 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CITOSPIN
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Sponsor organisation address |
Paseo de Belén, 11 Campus Miguel Delibes, Valladolid, Spain,
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Public contact |
Dr. Javier García-Sancho, CITOSPIN
, 34 983184827, jgsancho@uva.es
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Scientific contact |
Dr. Javier García-Sancho, CITOSPIN
, 34 983184827, jgsancho@uva.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Apr 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Dec 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Dec 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Feasibility and security of allogeneic bone marrow (MSCs) cells local use for degenerative disc disease treatment.
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Protection of trial subjects |
A continuous follow-up of adverse events was conducted through the study to detect and solve any discomfort or untoward medical occurrence that the patients may experience.
Besides the experimental treatment (MSC cells or control with 1% mepivacaine) the patients will receive the usual treatment based on rehabilitative physiotherapy, postural hygiene and pharmacotherapy.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Nov 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment was performed between July 2013 and March 2014. The study was conducted in only one center "Hospital Clínico Universitario de Valladolid - Spain" | |||||||||
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Pre-assignment
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Screening details |
Screening was done among patients with degenerative disease of 1 or 2 lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months. 26 patients were screened (1 decided no participate and 1 was excluded because received an incorrect number of cells). 24 subjects participated, | |||||||||
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Period 1
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Period 1 title |
Treatment
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [1] | |||||||||
Roles blinded |
Subject, Data analyst | |||||||||
Blinding implementation details |
While the investigator knew which treatment was administered to the patient, neither the patient nor the data analyst knew it. Procedures for both arms were the same, The test group received allogeneic bone marrow MSCs by intradiscal injection under local anesthesia and the control group received a sham infiltration of paravertebral musculature with the anesthetic. The nature of the treatments were code-protected so the blind is preserved to the analysist
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | |||||||||
Arm description |
12 patients were randomly allocated to this arm and received allogeneic bone marrow MSCs by intradiscal injection of 25×10e6 cells per segment under local anesthesia. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Allogenic bone marrow mesenquimal cells (MSCs)
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Investigational medicinal product code |
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Other name |
MSV
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradiscal use
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Dosage and administration details |
The product was administered in one intervention by intradiscal injection of 25×10e6 cells in 2 ml of saline suplemened with human albumin (0,5%) and glucose (5mM) per disc, under local anesthesia.
Bone marrow was obtained from 5 healthy donors and processed using GMP conditions in the IBGM Cell Production Unit. Isolations were carried out with the following parameters (mean ± SD; n = 5, 4 males and 1 woman): bone marrow volume = 10e5 ± 5 ml, average number of mononuclear cells obtained = 1.23 ± 0.25×10e9, expansion time = 27 ± 2 days, number of MSC injected into each disc = 25 ×10e6, suspended in Ringer-lactate at 12.5×1e06 cells/ml, and viability >98±1%. A serum sample from each donor was obtained to screen for human immunodeficiency, hepatitis B, and hepatitis C virus by Nucleic Acid Amplification Technology. The cells obtained from each donor were used for 1-3 recipients. Immune matching was not attempted.
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Arm title
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Active Control | |||||||||
Arm description |
12 patients were randomly assigned to the control group. All procedures were the same than the Experimental arm. 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). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Mepivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradiscal use
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Dosage and administration details |
The patients included in the control group received the treatment, mepivacain without MSC cells, in one intervention. They received a sham infiltration of paravertebral musculature with the anesthetic, 1% mepivacaine in each affected disc. The techniques and procedures were identical than the experimental arm.
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| Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The study has been categorized as double blind as only the investigators, that perfomed the intervention knew the treatment assigned to the patient. The patients, radiologists, care providers, and persons assessing the outcomes of the assay were blinded after assignment. |
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Period 2
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Period 2 title |
Follow Up
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [2] | |||||||||
Roles blinded |
Subject, Data analyst | |||||||||
Blinding implementation details |
While the investigator knew which treatment was administered to the patient, neither the patient nor
the data analyst knew it. Procedures for both arms were the same, The test group received allogeneic
bone marrow MSCs by intradiscal injection under local anesthesia and the control group received a sham
infiltration of paravertebral musculature with the anesthetic. The nature of the treatments were codeprotected
so the blind is preserved to the analysist
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | |||||||||
Arm description |
12 patients were randomly allocated to this arm and received allogeneic bone marrow MSCs by intradiscal injection of 25×10e6 cells per segment under local anesthesia. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Allogenic bone marrow mesenquimal cells (MSCs)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradiscal use
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Dosage and administration details |
The product was administered in one intervention by intradiscal injection of 25×10e6 cells in 2 ml of saline suplemened with human albumin (0,5%) and glucose (5mM) per disc, under local anesthesia.
Bone marrow was obtained from 5 healthy donors and processed using GMP conditions in the IBGM Cell Production Unit. Isolations were carried out with the following parameters (mean ± SD; n = 5, 4 males and 1 woman): bone marrow volume = 10e5 ± 5 ml, average number of mononuclear cells obtained = 1.23 ± 0.25×10e9, expansion time = 27 ± 2 days, number of MSC injected into each disc = 25 ×10e6, suspended in Ringer-lactate at 12.5×1e06 cells/ml, and viability >98±1%. A serum sample from each donor was obtained to screen for human immunodeficiency, hepatitis B, and hepatitis C virus by Nucleic Acid Amplification Technology. The cells obtained from each donor were used for 1-3 recipients. Immune matching was not attempted.
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Arm title
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Active Control | |||||||||
Arm description |
12 patients were randomly assigned to the control group. All the procedures were the same than the Experimental arm. The control group received a sham infiltration of paravertebral musculature with the anesthetic. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Mepivacaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradiscal use
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Dosage and administration details |
The patients included in the Control group received the treatment (Mepivacaine without MSC cells) in one intervention. They received a sham infiltration of paravertebral musculature with the anesthetic, 1% mepivacain in each affected disc. The techniques and procedures were identicaln than the experimental arm.
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| Notes [2] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The study has been categorized as double blind as only the investigators, that perfomed the intervention knew the treatment assigned to the patient. The patients, radiologists, care providers, and persons assessing the outcomes of the assay were blinded after assignment. |
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
A subject will be included in the analysis if he/she has been treated with MSC or active control as described in the protocol. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Efficacy
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This analysis included all the subjects that have been treated (either control or active cells), with no major protocol deviations and that had, at least, data from one efficacy assessment.
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Subject analysis set title |
Safety
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This set included all patients that have received the intervention (either control or allogeneic mesenchymal bone marrow cells)
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
12 patients were randomly allocated to this arm and received allogeneic bone marrow MSCs by intradiscal injection of 25×10e6 cells per segment under local anesthesia. | ||
Reporting group title |
Active Control
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Reporting group description |
12 patients were randomly assigned to the control group. All procedures were the same than the Experimental arm. 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). | ||
Reporting group title |
Experimental
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Reporting group description |
12 patients were randomly allocated to this arm and received allogeneic bone marrow MSCs by intradiscal injection of 25×10e6 cells per segment under local anesthesia. | ||
Reporting group title |
Active Control
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Reporting group description |
12 patients were randomly assigned to the control group. All the procedures were the same than the Experimental arm. The control group received a sham infiltration of paravertebral musculature with the anesthetic. | ||
Subject analysis set title |
Efficacy
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
This analysis included all the subjects that have been treated (either control or active cells), with no major protocol deviations and that had, at least, data from one efficacy assessment.
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Subject analysis set title |
Safety
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
This set included all patients that have received the intervention (either control or allogeneic mesenchymal bone marrow cells)
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End point title |
Safety [1] | ||||||||||||
End point description |
The number of participants with adverse events was used as a measure of safety and tolerability.
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End point type |
Primary
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End point timeframe |
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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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary objective of the study was to test the safety and tolerability of the intervention. Number of participants with adverse events was be used as a measure of safety and tolerability, but no further statisctical analysis was planned in the protocol at this stage of the development, for this primary outcome. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Pain and disability evolution | ||||||||||||
End point description |
Improvement 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.
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End point type |
Secondary
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End point timeframe |
Improvement since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Evolution of affected disc(s) by quantitative MRI Ratio 12/6months | ||||||||||||
End point description |
Ratio discs density betwewn 12 and 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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End point type |
Secondary
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End point timeframe |
From the baseline, prior the intervention, to the end of the follow-up, 12 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Physical Component 3 months | ||||||||||||
End point description |
Short form-12 (SF-12) of the physical component of the life quality questionnaire, measured 3 months after the intervention.
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End point type |
Secondary
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End point timeframe |
3 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Physical Component 6 months | ||||||||||||
End point description |
Physical component of the short form-12 (SF-12) life quality questionnaire measured 6 months after the intervention.
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End point type |
Secondary
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End point timeframe |
6 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Physical Component 12 months | ||||||||||||
End point description |
Physical component of the short form-12 (SF-12) life quality questionnaire measured 12 months after the intervention.
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End point type |
Secondary
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End point timeframe |
12 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Mental Component 3 months | ||||||||||||
End point description |
Mental component of the short form-12 (SF-12) life quality questionnaire measured 3 months after the intervention.
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End point type |
Secondary
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End point timeframe |
3 months after the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Mental Component 6 months | ||||||||||||
End point description |
Mental component of the short form-12 (SF-12) life quality questionnaire measured 6 months after the intervention.
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End point type |
Secondary
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End point timeframe |
6 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Mental Component 12 months | ||||||||||||
End point description |
Mental component of the short form-12 (SF-12) life quality questionnaire measured 12 months after the intervention.
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End point type |
Secondary
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End point timeframe |
12 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI): Density Before transplantation | ||||||||||||
End point description |
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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End point type |
Secondary
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End point timeframe |
Before intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI): Density at 6 months | ||||||||||||
End point description |
Measurement of the amount of luid 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.
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End point type |
Secondary
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End point timeframe |
6 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Evolution of affected disc(s) by quantitative RMI: Density at 12 months | ||||||||||||
End point description |
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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End point type |
Secondary
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End point timeframe |
12 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Physical Component: Baseline | ||||||||||||
End point description |
Results from the physical component of the short form-12 (SF-12) life quality questionnaire measured before the intervention.
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End point type |
Secondary
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End point timeframe |
Before intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
SF-12 Mental Component: Baseline | ||||||||||||
End point description |
Results from the mental component of the short form-12 (SF-12) life quality questionnaire measured before the intervention.
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End point type |
Secondary
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End point timeframe |
Before intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
VAS-Baseline | ||||||||||||
End point description |
Pain evaluation using a visual analogue scale (VAS) at baseline. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
Before the intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
VAS-3 months | ||||||||||||
End point description |
Subject's pain evaluation using a visual analogue scale (VAS) 3 months after intervention. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
3 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
VAS-6 months | ||||||||||||
End point description |
Subject's pain evaluation using a visual analogue scale (VAS) 6 months after intervention. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
6 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
VAS-12 months | ||||||||||||
End point description |
Subject's pain evaluation using a visual analogue scale (VAS) 12 months after intervention. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
12 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
ODI: Baseline | ||||||||||||
End point description |
Subject's Disability score in the Oswestry Disabiility Index (ODI) before intervention. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
Before intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
ODI: 3 months | ||||||||||||
End point description |
Subject's Disability score in the Oswestry Disabiility Index (ODI) 3 months after intervention. Outcomes are expressed using a 0%-100% escale.
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End point type |
Secondary
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End point timeframe |
3 months after intervention
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| No statistical analyses for this end point | |||||||||||||
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End point title |
ODI: 6 months | ||||||||||||
End point description |
Subject's Disability score in the Oswestry Disabiility Index (ODI) 6 months after intervention. Outcomes are expressed using a 0%-100% escale.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
6 months after intervention
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
ODI: 12 months | ||||||||||||
End point description |
Subject's Disability score in the Oswestry Disabiility Index (ODI) 12 months after intervention. Outcomes are expressed using a 0%-100% escale.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
12 months after intervention.
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Pfirrman stage: 6 months | ||||||||||||
End point description |
Assessment of nucleus pulposus evolution by Pfirrmann grading (1 to 5), which takes into account the structure of the disc, the distinction of nucleus pulposus and annulus fibrosus, the signal intensity and the height of the disc.
Evolution of the variable 6 months after intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
6 months after intervention
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Pfirrman stage: 12 months | ||||||||||||
End point description |
Assessment of nucleus pulposus evolution by Pfirrmann grading (1 to 5), which takes into account the structure of the disc, the distinction of nucleus pulposus and annulus fibrosus, the signal intensity and the height of the disc.
Evolution of the variable 12 months after the intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
12 months after intervention
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Pfirrman stage: Baseline | ||||||||||||
End point description |
Assessment of nucleus pulposus evolution by Pfirrmann grading (1 to 5), which takes into account the structure of the disc, the distinction of nucleus pulposus and annulus fibrosus, the signal intensity and the height of the disc.
|
||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Before intervention
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events reporting started when the patient signed the Informed Consent from, and lasted up to the last visit of each patient.
|
||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Only those events that were registered after the intervention were considered as Treatment emergent Adverse Events and reported.
|
||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Experimental
|
||||||||||||||||||||||||||||||
Reporting group description |
12 patients were randomly allocated to this arm and received allogeneic bone marrow MSCs by intradiscal injection of 25×10e6 cells per segment under local anesthesia. | ||||||||||||||||||||||||||||||
Reporting group title |
Control
|
||||||||||||||||||||||||||||||
Reporting group description |
12 patients were randomly assigned to the control group. All the procedures were the same than the Experimental arm. The control group received a sham infiltration of paravertebral musculature with the anesthetic. | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| 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 | |||
Online references |
|||
| http://www.ncbi.nlm.nih.gov/pubmed/27661661 |
|||
