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)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis of Jaw||Biological: MSC construct for Osteonecrosis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Rate of serious adverse events related to the procedure. [ Time Frame: 24 months from baseline ]Apparition of Bone ischemic events. Neoformations.
- 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.
- Time to Repair the injury [ Time Frame: 24 months from baseline ]
- Local pain assessed by visual analog scale [ Time Frame: 24 months from baseline ]
- Bone formation, measured by Computed tomography (mm) [ Time Frame: 24 months from baseline ]
- Quality of life, measured by EuroQol-5D. [ Time Frame: 24 months from baseline ]
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
|Contact: Natalia García Iniestafirstname.lastname@example.org|
|Hospital Clínico Virgen de la Arrixaca||Recruiting|
|El Palmar, Murcia, Spain, 30120|
|Contact: Natalia García Iniesta +34968381221 email@example.com|
|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|
|Principal Investigator:||Victor Villanueva San Vicente, MD||Hospital Universitario Virgen de la Arrixaca|
|Principal Investigator:||Francisco J Rodríguez Lozano, PhD||Universidad de Murcia|