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 Cellular Therapy Network (TerCel)

Status and phase: Unknown; Phase 1

Conditions: Osteonecrosis of Jaw

Treatments: Biological: MSC construct for Osteonecrosis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02566681

2012-005813-38 (EudraCT Number)

MSC/ONM

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MSC construct for Osteonecrosis

Experimental group

Description:

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).

Treatment:

Biological: MSC construct for Osteonecrosis