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

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

Interventions

  • Biological: MSC 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.

Arms, Groups and Cohorts

  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Red de Terapia Celular
  • Collaborator
    • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Victor Villanueva San Vicente, MD, Principal Investigator, Hospital Universitario Virgen de la Arrixaca
    • Francisco J Rodríguez Lozano, PhD, Principal Investigator, Universidad de Murcia
  • Overall Contact(s)
    • Natalia García Iniesta, +34968381221, nagarini@yahoo.es

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.