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Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV) (MSV-DISC)

Primary Purpose

Degenerative Disc Disease

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous bone marrow mesenchymal stem cells
Sponsored by
Red de Terapia Celular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Lumbar pain, Mesenchymal Stem Cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Magnetic Resonance Imaging (MRI; 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MSV autologous transplantation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain relief
    Pain is scored between 0 and 100 in Visual Analogue Scale for pain (VAS).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2015
    Last Updated
    May 6, 2015
    Sponsor
    Red de Terapia Celular
    Collaborators
    Instituto de Salud Carlos III, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02440074
    Brief Title
    Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)
    Acronym
    MSV-DISC
    Official Title
    Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not funded Administrative formalities not completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    November 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Red de Terapia Celular
    Collaborators
    Instituto de Salud Carlos III, University of Valladolid, Centro en Red de Medicina Regenerativa de Castilla y Leon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This trial pretends to validate for clinical use a bioengineered product composed of mesenchymal stem cells produced by the Instituto de Biologia y Genetica Molecular (IBGM), Valladolid (MSV, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. A phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region is proposed. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Follow up tests will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.
    Detailed Description
    The proposed test is based on previous animal experiments with positive results by the multidisciplinary team applicant, whose results are presented in paragraph 2.6 (group results Valladolid) and Annex I (group results Oviedo). The investigators propose phase I-II trial with 10 patients with a common condition and difficult to solve volumetric regeneration therapies, such as bone cysts in the maxillofacial region. Autologous mesenchymal cells isolated from a sample obtained from the cancellous bone of the tuberosity intraoral mandibular later and after expansion, will be conveyed in the matrix of autologous serum. The total process takes 6-8 weeks. After this time, perform the osteotomy and enucleation of the cyst under local anesthesia and the residual cavity is filled with bioimplant containing the MSV-H. Once the bioimplant, there will be clinical controls at 2 weeks, 2 and 6 months, to follow the evolution of regeneration by bone cavity in panoramic radiograph and CT scan. This project proposes a novel approach to therapy twice, combining a tissue engineering protocol (bioimplant) consisting of autologous mesenchymal cells have already been approved by the unit cell production of Valladolid (MSV-H), and a new protein matrix obtained autologous serum crosslinked in order to stimulate the regenerative capacity of maxillary cystic bone defects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease
    Keywords
    Lumbar pain, Mesenchymal Stem Cells

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MSV autologous transplantation
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Autologous bone marrow mesenchymal stem cells
    Other Intervention Name(s)
    MSV, mesenchymal stem cells by IBGM-Valladolid protocol.
    Intervention Description
    Bone marrow collection from patient, mesenchymal cells isolation and expansion under Good Manufacturing Practice (GMP) conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by intradiscal injection.
    Primary Outcome Measure Information:
    Title
    Pain relief
    Description
    Pain is scored between 0 and 100 in Visual Analogue Scale for pain (VAS).
    Time Frame
    Change from baseline at 12 months after intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 Magnetic Resonance Imaging (MRI; 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Lumbar Degenerative Disc Disease Treatment With Bone Marrow Autologous Mesenchymal Stem Cells (MSV)

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