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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABM seeded onto a porous TCP and DBM | Experimental | ABM seeded onto a porous TCP and DBM |
|
| autologous bone graft | Active Comparator | autologous bone graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABM seeded onto a porous TCP and DBM | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time needed to repair the focus of necrosis measured by pain radiography | Baseline and every 14 days up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scale | Baseline and every 14 days up to 180 days | |
| Technical success | Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Meseguer Olmo, MD,PhD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital UniversitarioVirgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| autologous bone graft | Procedure | autologous bone graft |
|
| 6 months |
| Morbidity | 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 | 6 months |
| Absence of adverse events | 6 months |
| physical exploratory | Baseline and every 14 days up to 180 days |
| Analgesia Scale | Baseline and every 14 days up to 180 days |
| ID | Term |
|---|---|
| D011542 | Pseudarthrosis |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004299 | Dopamine beta-Hydroxylase |
| ID | Term |
|---|---|
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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