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)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Osteonecrosis of Jaw
• Intervention / Treatment: Biological: MSC construct for Osteonecrosis

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Natalia García Iniesta; Phone Number: +34968381221; Email: nagarini@yahoo.es

Study Locations

• Spain
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Recruiting
      • Hospital Clínico Virgen de la Arrixaca
      • Contact: Natalia García Iniesta; Phone Number: +34968381221; Email: nagarini@yahoo.es
      • Principal Investigator: Victor Villanueva San Vicente, MD
      • Principal Investigator: Francisco J Rodríguez Lozano, PhD
      • Sub-Investigator: María A Rodríguez González, MD
      • Sub-Investigator: Daniel Segarra Fenoll, MD
      • Sub-Investigator: María M Gonzálvez García, MD
      • Sub-Investigator: José M Moraleda Jiménez, MD
      • Sub-Investigator: Miguel Blanquer Blanquer, MD
      • Sub-Investigator: Ana M García Hernández, MD
      • Sub-Investigator: Joaquín A Gómez Espuch, MD
      • Sub-Investigator: María Dolores López Lucas, Graduate
      • Sub-Investigator: Darío Sánchez Salinas, Graduate
      • Sub-Investigator: Francisca Iniesta Martínez, Graduate
      • Sub-Investigator: Carmen Algueró Martín, Graduate
      • Sub-Investigator: Francisca Velázquez Marín, MD
      • Sub-Investigator: Ricardo Oñate Sánchez, MD
      • Sub-Investigator: Luis Meseguer Olmo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Red de Terapia Celular
• Collaborators: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia; Hospital Universitario Virgen de la Arrixaca; Public Health Service, Murcia; Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca; Spanish National Health System
• Investigators: Principal Investigator: Victor Villanueva San Vicente, MD, Hospital Universitario Virgen de la Arrixaca; Principal Investigator: Francisco J Rodríguez Lozano, PhD, Universidad de Murcia

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis
• Other Study ID Numbers: MSC/ONM; 2012-005813-38 (EudraCT Number)