Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Red de Terapia Celular

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Red de Terapia Celular

Dates:
Date Received: January 30, 2015
Date Started: September 2015
Date Completion: December 2018
Last Updated: March 29, 2017
Last Verified: March 2017