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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01860417
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : April 26, 2017
University of Valladolid
Information provided by (Responsible Party):
Red de Terapia Celular

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, PEI 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).

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Intervertebral Disc Disease Low Back Pain Biological: Allogenic Mesenchymal Stromal Cells Drug: Mepivacaine Phase 1 Phase 2

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Biological: Allogenic Mesenchymal Stromal Cells
Other Names:
  • Mesenchymal stem cells (MSC)
  • MSC injection
  • MSV (MSV=MSC prepared following Valladolid IBGM procedure)

Active Comparator: Mepivacaine
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
Drug: Mepivacaine
Other Names:
  • Sham-treated comparator
  • Mepivacaine is also known as Carbocaine
  • Mepivacaine is also known as Polocaine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Llife quality evolution (Short Form (SF)-12 questionnaire) [ Time Frame: up to 1 year ]
    SF-12 scores at 0, 3, 3 and 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01860417

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Hospital Clinico Universitario
Valladolid, Spain, 47003
Instituto de Biologia y Genetica Molecular
Valladolid, Spain, 47003
Sponsors and Collaborators
Red de Terapia Celular
University of Valladolid
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Red de Terapia Celular Identifier: NCT01860417    
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:
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Spinal Diseases
Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Neurologic Manifestations
Bone Diseases
Musculoskeletal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents