NCT02566681
Unknown
Phase 1
Phase I Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis (MSC/ONM)
ConditionsOsteonecrosis of Jaw
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteonecrosis of Jaw
- Sponsor
- Red de Terapia Celular
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Rate of non-serious adverse events related to the procedure.
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety of use of autologous bone marrow stem cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and unblinded clinical trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of mandibular osteonecrosis of any etiology defined by clinical and radiological examination.
- •Bone defect anteroposterior dimension less than or equal to 4 cm in the mandible or the maxilla 2.5, and / or bone bed sufficient to ensure the integrity of the construct during surgery.
- •No response to conservative treatment.
- •Provide sufficient assurance of adherence to protocol.
- •Provide written consent
- •Meet all the inclusion criteria
Exclusion Criteria
- •Concomitant psychiatric illness.
- •Uncontrolled concomitant systemic disease.
- •Active infectious disease in the focus of mandibular osteonecrosis.
- •Neoplastic disease in complete remission less than 2 years.
- •Pregnant patients.
- •Patients with active feeding.
- •Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
- •Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
- •Inclusion in other clinical trials in active treatment.
- •Inability to understand the informed consent.
Outcomes
Primary Outcomes
Rate of non-serious adverse events related to the procedure.
Time Frame: 24 months from baseline
Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.
Rate of serious adverse events related to the procedure.
Time Frame: 24 months from baseline
Apparition of Bone ischemic events. Neoformations.
Secondary Outcomes
- Time to Repair the injury(24 months from baseline)
- Quality of life, measured by EuroQol-5D.(24 months from baseline)
- Local pain assessed by visual analog scale(24 months from baseline)
- Bone formation, measured by Computed tomography (mm)(24 months from baseline)
Study Sites (1)
Loading locations...
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