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OpenTrials
Completed

NCT Number: NCT01552707

Safety Study of Mesenchymal Stem Cells and Spinal Fusion

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.

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Key information

Conditions

Lumbar Spondylolisthesis Involving L4-L5, and/or Bone Diseases Degenerative Discopathy Involving L4-L5 Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XCEL-MT-OSTEO-ALPHA

Biological

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.

Standard treatment

Procedure

Instrumented spinal fusion together with patient's bone iliac crest

Primary outcomes

  1. 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

    Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months

  2. 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

    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 outcomes

  1. Efficacy spinal fusion by imaging procedures (X-Ray).

    Time frame: 3, 6 and 12 months

    Spinal fusion will be assessed by spinal X-Ray

  2. Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)

    Time frame: 6 and 12 months

    Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.

  3. Clinical outcomes (VAS)

    Time frame: 7 days and at 3, 6 and 12 months

    Pain measurement by visual analogue scale (VAS)

  4. Clinical outcomes (SF-36)

    Time frame: 3, 6 and 12 months

    This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36

  5. Clinical outcome (Oswestry Disability Index)

    Time frame: 3, 6 and 12 months

    To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain
  • Ministerio de Sanidad, Servicios Sociales e Igualdad
  • TFS Trial Form Support

Registry information

Official study title

"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Mar 13, 2012
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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