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)

• ClinicalTrials.gov Identifier: NCT02566681
• Recruitment Status: Unknown
• First Posted: October 2, 2015
• Last Update Posted: March 30, 2017
• Sponsor: Red de Terapia Celular
• Collaborators: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca; Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia; Hospital Universitario Virgen de la Arrixaca; Spanish National Health System; Public Health Service, Murcia
• Information provided by (Responsible Party): Red de Terapia Celular

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteonecrosis of Jaw	Biological: MSC construct for Osteonecrosis	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: September 2015
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Rate of serious adverse events related to the procedure. [ Time Frame: 24 months from baseline ]
   Apparition of Bone ischemic events. Neoformations.
2. 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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Natalia García Iniesta; +34968381221; nagarini@yahoo.es

Locations

Spain

Hospital Clínico Virgen de la Arrixaca; Recruiting

El Palmar, Murcia, Spain, 30120

Contact: Natalia García Iniesta +34968381221 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

Sponsors and Collaborators

Red de Terapia Celular

Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Hospital Universitario Virgen de la Arrixaca

Spanish National Health System

Public Health Service, Murcia

Investigators

• Principal Investigator: Victor Villanueva San Vicente, MD; Hospital Universitario Virgen de la Arrixaca
• Principal Investigator: Francisco J Rodríguez Lozano, PhD; Universidad de Murcia

More Information

• Responsible Party: Red de Terapia Celular
• ClinicalTrials.gov Identifier: NCT02566681
• Other Study ID Numbers: MSC/ONM; 2012-005813-38 ( EudraCT Number )
• First Posted: October 2, 2015
• Last Update Posted: March 30, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes