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Degenerative Disc DiseasePhase 1/2Disc_alloNCT01860417

Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)

A Phase 1/2 study testing Allogenic Mesenchymal Stromal Cells and Mepivacaine in people with Degenerative Disc Disease and Intervertebral Disc Disease, run by Red de Terapia Celular at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Allogenic Mesenchymal Stromal Cells and Mepivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesSpain
Study dates
21 Jun 2013to 15 Dec 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinico Universitario

    Valladolid, 47003

  • Instituto de Biologia y Genetica Molecular

    Valladolid, 47003

Other trials in Spain

About this study

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

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).

Being tested
Allogenic Mesenchymal Stromal Cells, Mepivacaine
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)
Medical subject headings
Intervertebral Disc Degeneration, Intervertebral disc disease, Low Back Pain, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic Mesenchymal Stromal CellsBiological

    Also called Mesenchymal stem cells (MSC), MSC injection, MSV (MSV=MSC prepared following Valladolid IBGM procedure)

  • MepivacaineDrug

    Also called Sham-treated comparator, Mepivacaine is also known as Carbocaine, Mepivacaine is also known as Polocaine

Study groups in NCT01860417
Study groupRoleWhat they receive
Allogenic Mesenchymal Stromal CellsExperimentalMesenchymal 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
Receives: Biological: Allogenic Mesenchymal Stromal Cells
MepivacaineActive comparatorInfiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
Receives: Drug: Mepivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention

Secondary outcomes (17)

  1. 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.

    Measured: At 12 months from 6 months after the intervention

  2. 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.

    Measured: At 6 months after the intervention

  3. 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.

    Measured: At 12 months after the intervention

  4. 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

    Measured: At 3 months after the intervention

  5. 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

    Measured: At 6 months after the intervention

  6. 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

    Measured: At 12 months after the intervention

  7. 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

    Measured: At 3 months after the intervention

  8. 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

    Measured: At 6 months after the intervention

  9. 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

    Measured: At 12 months after the intervention

  10. 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

    Measured: 3 months after the intervention

  11. 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

    Measured: 6 months after the intervention

  12. 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

    Measured: 12 months after the intervention

  13. 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

    Measured: 3 months after the intervention

  14. 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

    Measured: 6 months after the intervention

  15. 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

    Measured: 12 months after the intervention

  16. 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

    Measured: At 6 months after the intervention

  17. 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

    Measured: At 12 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2013 (estimated)
  2. Study start21 Jun 2013
  3. Primary completion15 Dec 2015
  4. Study completion15 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01860417
Sponsor's protocol ID
TerCel005
Other IDs
2012-004444-30, Disc_allo_MSV
Acronym
Disc_allo
Status last verified
Nov 2023
First submitted
18 May 2013
Last updated
29 Apr 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21792091

  • 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.

    PubMed 27661661

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogenic Mesenchymal Stromal Cells and Mepivacaine in people with Degenerative Disc Disease and Intervertebral Disc Disease, run by Red de Terapia Celular at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain and Disability Evaluation (time frame: Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860417, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.

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