NCT01552707

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Banc de Sang i Teixits · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-07-19
• Primary completion: 2018-05-03
• Completion: 2019-10-21
• First posted: 2012-03-13
• Last updated: 2020-01-21

Locations

5 sites across 1 country: Spain