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

Osteonecrosis of Jaw Clinical Trial

— MSC/ONM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02566681
• Other study ID #: MSC/ONM
• Secondary ID: 2012-005813-38
• Status: Recruiting
• Phase: Phase 1
• First received: January 30, 2015
• Last updated: March 29, 2017
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: Natalia García Iniesta
• Phone: +34968381221
• Email: nagarini[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of Jaw

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínico Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (6)

Lead Sponsor	Collaborator
Red de Terapia Celular	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Public Health Service, Murcia, Spanish National Health System

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of serious adverse events related to the procedure.	Apparition of Bone ischemic events. Neoformations.	24 months from baseline
Primary	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	Time to Repair the injury		24 months from baseline
Secondary	Local pain assessed by visual analog scale		24 months from baseline
Secondary	Bone formation, measured by Computed tomography (mm)		24 months from baseline
Secondary	Quality of life, measured by EuroQol-5D.		24 months from baseline