Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis
|Pseudoarthrosis||Procedure: ABM seeded onto a porous TCP and DBM Procedure: autologous bone graft||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis|
- Time needed to repair the focus of necrosis measured by pain radiography [ Time Frame: Baseline and every 14 days up to 180 days ]
- Pain scale [ Time Frame: Baseline and every 14 days up to 180 days ]
- Technical success [ Time Frame: 6 months ]Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells
- Morbidity [ Time Frame: 6 months ]Infection of extraction points Pathological fracture of the extraction area Muscle hernia Stress fracture Infection of focus repaired Rupture of the focus fixture repaired Appearance of secondary malignancies
- Absence of adverse events [ Time Frame: 6 months ]
- physical exploratory [ Time Frame: Baseline and every 14 days up to 180 days ]
- Analgesia Scale [ Time Frame: Baseline and every 14 days up to 180 days ]
|Study Start Date:||April 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: ABM seeded onto a porous TCP and DBM
ABM seeded onto a porous TCP and DBM
Procedure: ABM seeded onto a porous TCP and DBM
cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient.
Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM)
Active Comparator: autologous bone graft
autologous bone graft
Procedure: autologous bone graft
autologous bone graft
An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.
Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.
Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.
Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.
On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.
Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.
The investigators have designed a phase II clinical trial to check the feasibility of this approach.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813188
|Hospital UniversitarioVirgen de la Arrixaca|
|El Palmar, Murcia, Spain, 30120|
|Principal Investigator:||Luis Meseguer Olmo, MD,PhD||Hospital Universitario Virgen de la Arrixaca|