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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)

Primary Purpose

Osteonecrosis of Jaw

Status

Unknown status

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

MSC construct for Osteonecrosis

About this trial

This is an interventional treatment trial for Osteonecrosis of Jaw

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Clínico Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC construct for Osteonecrosis

Arm 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).

Outcomes

Primary Outcome Measures

Rate of serious adverse events related to the procedure.

Apparition of Bone ischemic events. Neoformations.

Rate of non-serious adverse events related to the procedure.

Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.

Secondary Outcome Measures

Time to Repair the injury

Local pain assessed by visual analog scale

Bone formation, measured by Computed tomography (mm)

Quality of life, measured by EuroQol-5D.

Full Information

NCT ID

NCT02566681

First Posted

January 30, 2015

Last Updated

March 29, 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

1. Study Identification

Unique Protocol Identification Number

NCT02566681

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Red de Terapia Celular

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteonecrosis of Jaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC construct for Osteonecrosis

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

MSC construct for Osteonecrosis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of serious adverse events related to the procedure.

Description

Apparition of Bone ischemic events. Neoformations.

Time Frame

24 months from baseline

Title

Rate of non-serious adverse events related to the procedure.

Description

Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.

Time Frame

24 months from baseline

Secondary Outcome Measure Information:

Title

Time to Repair the injury

Time Frame

24 months from baseline

Title

Local pain assessed by visual analog scale

Time Frame

24 months from baseline

Title

Bone formation, measured by Computed tomography (mm)

Time Frame

24 months from baseline

Title

Quality of life, measured by EuroQol-5D.

Time Frame

24 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Natalia García Iniesta

Phone

+34968381221

nagarini@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor Villanueva San Vicente, MD

Organizational Affiliation

Hospital Universitario Virgen de la Arrixaca

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francisco J Rodríguez Lozano, PhD

Organizational Affiliation

Universidad de Murcia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínico Virgen de la Arrixaca

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Natalia García Iniesta

Phone

+34968381221

nagarini@yahoo.es

First Name & Middle Initial & Last Name & Degree

Victor Villanueva San Vicente, MD

First Name & Middle Initial & Last Name & Degree

Francisco J Rodríguez Lozano, PhD

First Name & Middle Initial & Last Name & Degree

María A Rodríguez González, MD

First Name & Middle Initial & Last Name & Degree

Daniel Segarra Fenoll, MD

First Name & Middle Initial & Last Name & Degree

María M Gonzálvez García, MD

First Name & Middle Initial & Last Name & Degree

José M Moraleda Jiménez, MD

First Name & Middle Initial & Last Name & Degree

Miguel Blanquer Blanquer, MD

First Name & Middle Initial & Last Name & Degree

Ana M García Hernández, MD

First Name & Middle Initial & Last Name & Degree

Joaquín A Gómez Espuch, MD

First Name & Middle Initial & Last Name & Degree

María Dolores López Lucas, Graduate

First Name & Middle Initial & Last Name & Degree

Darío Sánchez Salinas, Graduate

First Name & Middle Initial & Last Name & Degree

Francisca Iniesta Martínez, Graduate

First Name & Middle Initial & Last Name & Degree

Carmen Algueró Martín, Graduate

First Name & Middle Initial & Last Name & Degree

Francisca Velázquez Marín, MD

First Name & Middle Initial & Last Name & Degree

Ricardo Oñate Sánchez, MD

First Name & Middle Initial & Last Name & Degree

Luis Meseguer Olmo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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