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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteonecrosis of Jaw

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

MSC construct for Osteonecrosis

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No