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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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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Locations

Spain
Hospital Clinico Universitario
Valladolid, Spain, 47003
Instituto de Biologia y Genetica Molecular
Valladolid, Spain, 47003

Sponsors and Collaborators

Red de Terapia Celular

Citospin

University of 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Treatment of Degenerative Disc Disease with Autologous Mesenchymal Stem Cells 

Spanish Cell Therapy Network 

Citospin S.L. (MSV Cell Production) 

Intervertebral disk 

mesenchymal stem cells 

Publications:

Orozco L, Soler R, Morera C, Alberca M, Sánchez A, García-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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Noriega DC, Ardura F, Hernández-Ramajo R, Martín-Ferrero MÁ, Sánchez-Lite I, Toribio B, Alberca M, García V, Moraleda JM, Sánchez A, García-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.

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
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