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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Citospin, S.L., Valladolid, Spain
Scientific Park Foundation of Valladolid University
Instituto de Biologia y Genetica Molecular (IBGM) de Valladolid
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01860417
First received: May 18, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Degenerative Disc Disease
Intervertebral Disc Disease
Low Back Pain
Biological: Allogenic Mesenchymal Stromal Cells
Drug: Mepivacaine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Red de Terapia Celular:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
    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:
  • Pain and disability evolution [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SF-12 scores at 0, 3, 3 and 12 months


Estimated Enrollment: 24
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01860417

Locations
Spain
Instituto de Biologia y Genetica Molecular
Valladolid, Spain, 47003
Hospital Clinico Universitario
Valladolid, Spain, 47003
Sponsors and Collaborators
Red de Terapia Celular
Citospin, S.L., Valladolid, Spain
Scientific Park Foundation of Valladolid University
Instituto de Biologia y Genetica Molecular (IBGM) de Valladolid
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01860417     History of Changes
Other Study ID Numbers: TerCel005, 2012-004444-30, Disc_allo_MSV
Study First Received: May 18, 2013
Last Updated: June 19, 2014
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health

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
Spinal Diseases
Low Back Pain
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014