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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566681
Recruitment Status : Unknown
Verified March 2017 by Red de Terapia Celular.
Recruitment status was:  Recruiting
First Posted : October 2, 2015
Last Update Posted : March 30, 2017
Sponsor:
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

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.





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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566681


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

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

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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    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes