Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis

Red de Terapia Celular10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteonecrosis of Jaw

Interventions

MSC construct for OsteonecrosisBIOLOGICAL

30 days before implanting the construct made with MSC + TP + DBM, bone marrow of patients diagnosed with osteonecrosis of the jaw included in the clinical trial is obtained. The bone marrow will be obtained according to standard practice for Hematologists of the Haematology University Hospital Virgen de la Arrixaca (HCUVA). Mononuclear bone marrow cells were separated and cultured in GMP conditions (Good Manufacturing Practices). The cells are seeded on tricalcium phosphate and maintained in culture for 14 days. The day when the implant is performed, the patient is prepared in the operating room. The area where the implant will be placed is cleaned. Mesenchymal cells seeded in tricalcium phosphate are mixed with demineralized bone matrix and It's coagulated with autologous platelet rich plasma and grafting is performed. Finally, the oral mucosa or skin will be sealingly closed by silk sutures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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. * You need not meet any exclusion criteria

Locations (1)

Hospital Clínico Virgen de la Arrixaca

El Palmar, Murcia, Spain

RECRUITING