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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Osteonecrosis of Jaw

Intervention / Treatment
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* Biological: MSC construct for Osteonecrosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC construct for Osteonecrosis<br>Patients with definite diagnosis of osteonecrosis of the jaw by clinical and radiological examination of any etiology will receive a construct made of Bone Marrow Stem Cell + Tricalcium Phosphate + Demineralized Bone Matrix (MSC+TP+DBM). | Biological: MSC construct for Osteonecrosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious adverse events related to the procedure. | Apparition of Bone ischemic events. Neoformations. | 24 months from baseline | 
| Rate of non-serious adverse events related to the procedure. | Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions. | 24 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |