Osteonecrosis of Jaw
Conditions
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.
Interventions
BIOLOGICALMSC construct for Osteonecrosis
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.
Sponsors
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Spanish National Health System
Public Health Service, Murcia
Red de Terapia Celular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of serious adverse events related to the procedure. | 24 months from baseline | Apparition of Bone ischemic events. Neoformations. |
| Rate of non-serious adverse events related to the procedure. | 24 months from baseline | Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions. |
Secondary
| Measure | Time frame |
|---|---|
| Time to Repair the injury | 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 |
| Quality of life, measured by EuroQol-5D. | 24 months from baseline |
Countries
Spain
Contacts
Primary ContactNatalia García Iniesta
Outcome results
None listed