Safety Study of Mesenchymal Stem Cells and Spinal Fusion
This study is currently recruiting participants.
Verified June 2012 by Banc de Sang i Teixits
Sponsor:
Banc de Sang i Teixits
Collaborators:
TFS Trial Form Support
Funded by the Spanish government (Ministerio Ministerio de Sanidad, Política Social e Igualdad)
Cofunded by the Spanish government (Ministerio de Ciencia e Innovación) and European Union (European Regional development Fund (ERDF))
Information provided by (Responsible Party):
Banc de Sang i Teixits
ClinicalTrials.gov Identifier:
NCT01552707
First received: March 8, 2012
Last updated: June 20, 2012
Last verified: June 2012
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Purpose
The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchyimal 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 |
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: | November 2014 |
| Estimated Primary Completion Date: | June 2014 (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 phaseI-II clinical trial in which 62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to Meyerding 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
- 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
- Smoker (more than 5 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)
- 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 thar could exceed the clinical trial length
- The patient is legally dependent
Contacts and Locations
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
Funded by the Spanish government (Ministerio Ministerio de Sanidad, Política Social e Igualdad)
Cofunded by the Spanish government (Ministerio de Ciencia e Innovación) and European Union (European Regional development Fund (ERDF))
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: | June 20, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Banc de Sang i Teixits:
|
Spondylolisthesis 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 May 21, 2013