Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV) (Disc_allo)
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ClinicalTrials.gov Identifier: NCT01860417 |
Recruitment Status
:
Completed
First Posted
: May 22, 2013
Last Update Posted
: April 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Degenerative Disc Disease Intervertebral Disc Disease Low Back Pain | Biological: Allogenic Mesenchymal Stromal Cells Drug: Mepivacaine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Lumbar Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Bone Marrow Mesenchymal Stromal Cells Expanded Using the Valladolid IBGM Procedure |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | April 2017 |
Actual Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
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Experimental: 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
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Biological: Allogenic Mesenchymal Stromal Cells
Other Names:
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Active Comparator: Mepivacaine
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
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Drug: Mepivacaine
Other Names:
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- Safety and tolerability [ Time Frame: up to one year ]Number of participants with adverse events will be used as a measure of safety and tolerability. Adverse events reported: clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
- Pain and disability evolution [ Time Frame: up to 1 year ]Clinical review and questionaires (Visual Analogue Scales (VAS) and Oswestry questionnaires) at 0, 3, 6 and 12 months.
- Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (RMI) [ Time Frame: up to one year ]RMI density measurements in T2 weighted images performed at 0, 6 and 12 months used as an indication of disc fluid content
- Llife quality evolution (Short Form (SF)-12 questionnaire) [ Time Frame: up to 1 year ]SF-12 scores at 0, 3, 3 and 12 months

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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 RMI image (stages 2, 3 and 4 of Adams).
- Decrease of disc height of more than 20% (radiographic measurement in side image).
- Absence of spinal infection.
- Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
- The patient is able to understand the nature of the study.
- Informed written consent of the patient.
Exclusion Criteria:
- Age over 75 or under 18 or legally dependent
- Allergy to gentamicin, or to bovine, cattle or horse serum.
- Congenital or acquired diseases leading to spine deformations that may upset cell application.
- Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
- Modic III changes on MRI images (31).
- Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
- Pregnancy or breast-feeding
- Neoplasia
- Immunosuppression
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Other conditions that may, according to medical criteria, discourage participation in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860417
Spain | |
Hospital Clinico Universitario | |
Valladolid, Spain, 47003 | |
Instituto de Biologia y Genetica Molecular | |
Valladolid, Spain, 47003 |
Study Chair: | Javier Garcia-Sancho, MD, PhD | Scientific Park Foundation of University of Valladolid | |
Study Director: | David C Noriega, MD, PhD | Hospital Clinico Universitario, Valladolid | |
Study Director: | Ana Sanchez, MD, PhD | Citospin | |
Principal Investigator: | FRancisco Ardura, MD, PhD | Hospital Clinico Universitario, Valladolid |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Red de Terapia Celular |
ClinicalTrials.gov Identifier: | NCT01860417 History of Changes |
Other Study ID Numbers: |
TerCel005 2012-004444-30 ( EudraCT Number ) Disc_allo_MSV ( Other Identifier: Red TerCel ) |
First Posted: | May 22, 2013 Key Record Dates |
Last Update Posted: | April 26, 2017 |
Last Verified: | April 2017 |
Keywords provided by Red de Terapia Celular:
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) |
Additional relevant MeSH terms:
Back Pain Low Back Pain Spinal Diseases Intervertebral Disc Degeneration Intervertebral Disc Displacement Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bone Diseases |
Musculoskeletal Diseases Hernia Pathological Conditions, Anatomical Mepivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |