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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)

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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
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

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteonecrosis of Jaw
Intervention  ICMJE 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.

Study Arms  ICMJE 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).
Intervention: Biological: MSC construct for Osteonecrosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02566681
Other Study ID Numbers  ICMJE MSC/ONM
2012-005813-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Red de Terapia Celular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Red de Terapia Celular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Victor Villanueva San Vicente, MD Hospital Universitario Virgen de la Arrixaca
Principal Investigator: Francisco J Rodríguez Lozano, PhD Universidad de Murcia
PRS Account Red de Terapia Celular
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP