Clinical Trial of Use of Autologous Bone Marrow Stem Cell... | NCT02566681 | Trialant
NCT02566681
Sponsor
Red de Terapia Celular
Status
Unknown status
Last Update Posted
Mar 30, 2017Actual
Enrollment
10Estimated
Phase
Phase 1
Conditions
Osteonecrosis of Jaw
Interventions
MSC construct for Osteonecrosis
Countries
Spain
Protocol Section
Identification Module
NCT ID
NCT02566681
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MSC/ONM
Secondary IDs
ID
Type
Description
Link
2012-005813-38
EudraCT Number
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
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)
Acronym
MSC/ONM
Organization
Red de Terapia CelularINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2015
Primary Completion Date
Dec 2018Estimated
Completion Date
Dec 2018Estimated
First Submitted Date
Jan 30, 2015
First Submission Date that Met QC Criteria
Sep 30, 2015
First Posted Date
Oct 2, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 29, 2017
Last Update Posted Date
Mar 30, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Red de Terapia CelularINDUSTRY
Collaborators
Name
Class
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
OTHER
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
OTHER
Hospital Universitario Virgen de la Arrixaca
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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
Conditions Module
Conditions
Osteonecrosis of Jaw
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
10Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MSC construct for Osteonecrosis
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MSC construct for Osteonecrosis
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Rate of serious adverse events related to the procedure.
Apparition of Bone ischemic events. Neoformations.
24 months from baseline
Rate of non-serious adverse events related to the procedure.
Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.
24 months from baseline
Secondary Outcomes
Measure
Description
Time Frame
Time to Repair the injury
24 months from baseline
Local pain assessed by visual analog scale
24 months from baseline
Bone formation, measured by Computed tomography (mm)
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Natalia García Iniesta
Contact
+34968381221
nagarini@yahoo.es
Overall Officials
Name
Affiliation
Role
Victor Villanueva San Vicente, MD
Hospital Universitario Virgen de la Arrixaca
Principal Investigator
Francisco J Rodríguez Lozano, PhD
Universidad de Murcia
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Hospital Clínico Virgen de la Arrixaca
Recruiting
El Palmar
Murcia
30120
Spain
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
OTHER
Spanish National Health System
OTHER
Public Health Service, Murcia
OTHER
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MSC construct for Osteonecrosis
24 months from baseline
Quality of life, measured by EuroQol-5D.
24 months from baseline
Natalia García IniestaContact+34968381221nagarini@yahoo.es
Victor Villanueva San Vicente, MDPrincipal Investigator
Francisco J Rodríguez Lozano, PhDPrincipal Investigator
María A Rodríguez González, MDSub-Investigator
Daniel Segarra Fenoll, MDSub-Investigator
María M Gonzálvez García, MDSub-Investigator
José M Moraleda Jiménez, MDSub-Investigator
Miguel Blanquer Blanquer, MDSub-Investigator
Ana M García Hernández, MDSub-Investigator
Joaquín A Gómez Espuch, MDSub-Investigator
María Dolores López Lucas, GraduateSub-Investigator