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

NCT01860417 | Completed Phase 1 Results DMC

• 3 other identifiers: TerCel0052012-004444-30Disc_allo_MSV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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, 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).

Conditions

Degenerative Disc Disease; Intervertebral Disc Disease; Low Back Pain

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)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (17)

• Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months

  At 12 months from 6 months after the intervention

• Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months

  At 6 months after the intervention

• Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months

  At 12 months after the intervention

• Visual Analogue Scale at 3 Months

  At 3 months after the intervention

• Visual Analogue Scale at 6 Months

  At 6 months after the intervention

Study Arms (2)

Allogenic Mesenchymal Stromal Cells

EXPERIMENTAL

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

Mepivacaine

ACTIVE COMPARATOR

Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine

Drug: Mepivacaine

Interventions

Allogenic Mesenchymal Stromal Cells BIOLOGICAL

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

Allogenic Mesenchymal Stromal Cells

Mepivacaine DRUG

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

Mepivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Other conditions that may, according to medical criteria, discourage participation in the study.

Sponsors & Collaborators

• Red de Terapia Celular: lead
• Citospin: collaborator
• University of Valladolid: collaborator

Study Sites (2)

Hospital Clinico Universitario

Valladolid, 47003, Spain

Location

Instituto de Biologia y Genetica Molecular

Valladolid, 47003, Spain

Location

Related Publications (2)

• 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.

  PMID: 21792091 BACKGROUND

• 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.

  PMID: 27661661 DERIVED

Related Links

• Treatment of Degenerative Disc Disease with Autologous Mesenchymal Stem Cells
• Instituto de Biologia y Genética Molecular IBGM), Cell Production Research
• Intervertebral disk
• mesenchymal stem cells

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease; Low Back Pain; Musculoskeletal Diseases

Interventions

Genes, mos; Mepivacaine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Further studies shall track the long-term evolution as well as investigate the anatomical and functional changes that occur in the intervertebral spaces and shall increase the number of patients, which was an important limitation of the present study

Results Point of Contact

• Title: Dr. Javier García-Sancho,
• Organization: CITOSPIN

jgsancho@uva.es

0034 983184827

Study Officials

• Javier Garcia-Sancho, MD, PhD

  Scientific Park Foundation of University of Valladolid

  STUDY CHAIR

• David C Noriega, MD, PhD

  Hospital Clinico Universitario, Valladolid

  STUDY DIRECTOR

• Ana Sanchez, MD, PhD

  Citospin

  STUDY DIRECTOR

• FRancisco Ardura, MD, PhD

  Hospital Clinico Universitario, Valladolid

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: May 22, 2013
• Study Start: June 21, 2013
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

Locations

ES (2)