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

March 8, 2012
July 16, 2014
June 2012
December 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01552707 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lumbar Spondylolisthesis Involving L4-L5, and/or
  • Degenerative Discopathy Involving L4-L5
  • 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.
  • Procedure: Standard treatment
    Instrumented spinal fusion together with patient's bone iliac crest
  • Experimental: XCEL-MT-OSTEO-ALPHA
    "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion
    Intervention: Biological: XCEL-MT-OSTEO-ALPHA
  • Sham Comparator: Standard treatment
    Instrumented spinal fusion together with patient's bone iliac crest.
    Intervention: Procedure: Standard treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
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
Spain
 
NCT01552707
XCEL-MT-10-02
No
Banc de Sang i Teixits
Banc de Sang i Teixits
  • TFS Trial Form Support
  • Ministerio de Sanidad, Servicios Sociales e Igualdad
  • Ministerio de Ciencia e Innovación, Spain
Principal Investigator: Enric Cáceres, MD, PhD Hospital Universitari Vall d'Hebron
Banc de Sang i Teixits
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP