Safety Study of Mesenchymal Stem Cells and Spinal Fusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Banc de Sang i Teixits
Sponsor:
Collaborators:
TFS Trial Form Support
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Banc de Sang i Teixits
ClinicalTrials.gov Identifier:
NCT01552707
First received: March 8, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.


Condition Intervention Phase
Lumbar Spondylolisthesis Involving L4-L5, and/or
Degenerative Discopathy Involving L4-L5
Biological: XCEL-MT-OSTEO-ALPHA
Procedure: Standard treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease

Further study details as provided by Banc de Sang i Teixits:

Primary Outcome Measures:
  • safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months

  • Feasibility of XCEL-MT-OSTEO-ALPHA (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.


Secondary Outcome Measures:
  • Efficacy spinal fusion by imaging procedures (X-Ray). [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Spinal fusion will be assessed by spinal X-Ray

  • Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.

  • Clinical outcomes (VAS) [ Time Frame: 7 days and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    Pain measurement by visual analogue scale (VAS)

  • Clinical outcomes (SF-36) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36

  • Clinical outcome (Oswestry Disability Index) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index


Estimated Enrollment: 62
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XCEL-MT-OSTEO-ALPHA
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion
Biological: XCEL-MT-OSTEO-ALPHA
Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion.
Sham Comparator: Standard treatment
Instrumented spinal fusion together with patient's bone iliac crest.
Procedure: Standard treatment
Instrumented spinal fusion together with patient's bone iliac crest

Detailed Description:

Prospective, open-label, randomized, parallel, single-dose phase I-II clinical trial in which 62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to Meyerding and/or with L4-L5 degenerative discopathy needing spinal fusion will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion. Secondary objectives are to assess the efficacy of the implantation by imaging (computerized helicoidal tomography and X-ray) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and Oswestry Disability Index).

Patients will be randomized to one of the two treatment arms (instrumented spinal fusion and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion or the standard treatment of instrumented spinal fusion and patient's bone iliac crest). Thereafter, patients will be followed for 12 months.

Imaging assessment will be done by an independent blinded radiologist.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level.
  • 18 to 85 years of age (male and female)
  • Informed Consent Form signed
  • The patient is able to understand the nature of the study

Exclusion Criteria:

  • Previous spine surgery
  • L4 isthmic spondylolisthesis
  • Smoker (more than 10 cigarettes a day)
  • Systemic or local infection
  • Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
  • Pregnant woman or intended to become pregnant, or breath feeding
  • Neoplasia within the previous 5 years, or without remission
  • Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed)
  • Significant abnormal laboratory tests that contraindicates the surgery.
  • Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  • The patient does not accept to be followed-up for a period that could exceed the clinical trial length
  • The patient is legally dependent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552707

Contacts
Contact: Ruth Coll, MD +34 93 557 3500 ext 6707 rucoll@bst.cat
Contact: Joan Garcia, MD, PhD +34 93 557 3500 joangarcia@bst.cat

Locations
Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact       maiteubi8587@gmail.com   
Principal Investigator: Maite Ubierna, MD, PhD         
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact       ecaceres@vhebron.net   
Contact       ana_garcia@vhebron.net   
Principal Investigator: Enric Cáceres, MD, PhD         
Sub-Investigator: Ana García de Frutos, MD, PhD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact       alexdelarco2502@hotmail.com   
Principal Investigator: Alex del Arco, MD, PhD         
Parc de Salut Mar Recruiting
Barcelona, Spain, 08003
Contact       ALlado@parcdesalutmar.cat   
Principal Investigator: Andreu Lladó, MD, PhD         
Institut Universitari Dexeus (ICATME) Recruiting
Barcelona, Spain, 08028
Contact       ecaceres@vhebron.net   
Principal Investigator: Enric Cáceres, MD, PhD         
Sponsors and Collaborators
Banc de Sang i Teixits
TFS Trial Form Support
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
Investigators
Principal Investigator: Enric Cáceres, MD, PhD Hospital Universitari Vall d'Hebron
  More Information

Additional Information:
No publications provided

Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT01552707     History of Changes
Other Study ID Numbers: XCEL-MT-10-02
Study First Received: March 8, 2012
Last Updated: July 16, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Banc de Sang i Teixits:
Spondylolisthesis
Degenerative discopathy
Mesenchymal Stem Cells
Bone marrow
Tissue engineering
Spinal fusion

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014