Pseudoarthrosis Clinical Trial
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
The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with 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.
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