Clinical Trial: Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
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 tr
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Current Primary Outcome: Time needed to repair the focus of necrosis measured by pain radiography [ Time Frame: Baseline and every 14 days up to 180 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Dates:
Date Received: June 22, 2011
Date Started: April 2011
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2014
