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

Phase 1

• Conditions: Osteonecrosis of Jaw
• Interventions: Biological: MSC construct for Osteonecrosis

• Registration Number: NCT02566681
• Lead Sponsor: Red de Terapia Celular

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC construct for Osteonecrosis	MSC construct for Osteonecrosis	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Local pain assessed by visual analog scale	24 months from baseline
Bone formation, measured by Computed tomography (mm)	24 months from baseline
Time to Repair the injury	24 months from baseline
Quality of life, measured by EuroQol-5D.	24 months from baseline

Trial Locations

Locations (1)

Hospital Clínico Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain