Clinical trial NCT02566681: Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteonecrosis of Jaw
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
name: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
name: Hospital Universitario Virgen de la Arrixaca
name: Spanish National Health System
name: Public Health Service, Murcia
First posted: 2015-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.
* You need not meet any exclusion criteria

Primary outcomes:
measure: Rate of serious adverse events related to the procedure.
timeFrame: 24 months from baseline
measure: Rate of non-serious adverse events related to the procedure.
timeFrame: 24 months from baseline
Secondary outcomes:
measure: Time to Repair the injury
timeFrame: 24 months from baseline
measure: Local pain assessed by visual analog scale
timeFrame: 24 months from baseline
measure: Bone formation, measured by Computed tomography (mm)
timeFrame: 24 months from baseline
measure: Quality of life, measured by EuroQol-5D.
timeFrame: 24 months from baseline
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Hospital Clínico Virgen de la Arrixaca
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Victor Villanueva San Vicente, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: Francisco J Rodríguez Lozano, PhD
role: PRINCIPAL_INVESTIGATOR
References: