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Safety Study of Mesenchymal Stem Cells and Spinal Fusion

Primary Purpose

Lumbar Spondylolisthesis Involving L4-L5, and/or, Degenerative Discopathy Involving L4-L5

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
XCEL-MT-OSTEO-ALPHA
Standard treatment
Sponsored by
Banc de Sang i Teixits
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylolisthesis Involving L4-L5, and/or focused on measuring Spondylolisthesis, Degenerative discopathy, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Spinal fusion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol
  • Parc de Salut Mar
  • Hospital de la Santa Creu i Sant Pau
  • Institut Universitari Dexeus (ICATME)
  • Hospital Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

XCEL-MT-OSTEO-ALPHA

Standard treatment

Arm Description

"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion

Instrumented spinal fusion together with patient's bone iliac crest.

Outcomes

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)
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)
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).
Spinal fusion will be assessed by spinal X-Ray
Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)
Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.
Clinical outcomes (VAS)
Pain measurement by visual analogue scale (VAS)
Clinical outcomes (SF-36)
This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
Clinical outcome (Oswestry Disability Index)
To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index

Full Information

First Posted
March 8, 2012
Last Updated
January 15, 2020
Sponsor
Banc de Sang i Teixits
Collaborators
TFS Trial Form Support, Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01552707
Brief Title
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
Official Title
"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2012 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
TFS Trial Form Support, Ministerio de Sanidad, Servicios Sociales e Igualdad, Ministerio de Ciencia e Innovación, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylolisthesis Involving L4-L5, and/or, Degenerative Discopathy Involving L4-L5
Keywords
Spondylolisthesis, Degenerative discopathy, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Spinal fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XCEL-MT-OSTEO-ALPHA
Arm Type
Experimental
Arm Description
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion
Arm Title
Standard treatment
Arm Type
Sham Comparator
Arm Description
Instrumented spinal fusion together with patient's bone iliac crest.
Intervention Type
Biological
Intervention Name(s)
XCEL-MT-OSTEO-ALPHA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard treatment
Intervention Description
Instrumented spinal fusion together with patient's bone iliac crest
Primary Outcome Measure Information:
Title
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)
Description
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Time Frame
12 months
Title
Feasibility of XCEL-MT-OSTEO-ALPHA (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy spinal fusion by imaging procedures (X-Ray).
Description
Spinal fusion will be assessed by spinal X-Ray
Time Frame
3, 6 and 12 months
Title
Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)
Description
Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.
Time Frame
6 and 12 months
Title
Clinical outcomes (VAS)
Description
Pain measurement by visual analogue scale (VAS)
Time Frame
7 days and at 3, 6 and 12 months
Title
Clinical outcomes (SF-36)
Description
This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
Time Frame
3, 6 and 12 months
Title
Clinical outcome (Oswestry Disability Index)
Description
To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Bagó, MD, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Institut Universitari Dexeus (ICATME)
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25769789
Citation
Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.
Results Reference
derived
Links:
URL
http://www.bancsang.net
Description
Banc de Sang i Teixits. Xcelia, División de Terapias Avanzadas.
URL
http://www.icatme.com
Description
Institut Català de Traumatologia i Medicina de l'Esport (Institut Universitari Dexeus)
URL
http://www.vhebron.net
Description
Hospital Universitari Vall d'Hebron, Barcelona
URL
http://www.gencat.cat/ics/germanstrias/
Description
Hospital Universitari Germans Trias i Pujol, Badalona
URL
http://www.parcdesalutmar.cat
Description
Hospital Parc de Salut Mar, Barcelona
URL
http://www.santpau.es/
Description
Hospital de la Santa Creu i Sant Pau, Barcelona

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Safety Study of Mesenchymal Stem Cells and Spinal Fusion

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