Osteonecrosis of JawPhase 1MSC/ONMNCT02566681
Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis
A Phase 1 study testing MSC construct for Osteonecrosis in people with Osteonecrosis of Jaw, run by Red de Terapia Celular at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteonecrosis of Jaw
- What is being tested?
- MSC construct for Osteonecrosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Inability to understand the informed consent.
- You need not meet any exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia, 30120
Natalia García Iniesta, +34968381221, nagarini@yahoo.es
Victor Villanueva San Vicente, MD
About this study
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)
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.
- Conditions
- Osteonecrosis of Jaw
- Being tested
- MSC construct for Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC construct for OsteonecrosisBiological
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: MSC construct for Osteonecrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of serious adverse events related to the procedure.
Apparition of Bone ischemic events. Neoformations.
Measured: 24 months from baseline
Rate of non-serious adverse events related to the procedure.
Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.
Measured: 24 months from baseline
Secondary outcomes (4)
Time to Repair the injury
Measured: 24 months from baseline
Local pain assessed by visual analog scale
Measured: 24 months from baseline
Bone formation, measured by Computed tomography (mm)
Measured: 24 months from baseline
Quality of life, measured by EuroQol-5D.
Measured: 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Victor Villanueva San Vicente, MD, Principal investigator, Hospital Universitario Virgen de la ArrixacaFrancisco J Rodríguez Lozano, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566681
- Sponsor's protocol ID
- MSC/ONM
- Other IDs
- 2012-005813-38
- Acronym
- MSC/ONM
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02566681
- Acronym / sponsor ID
- MSC/ONM / MSC/ONM
- Conditions
- Osteonecrosis of Jaw
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- 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
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC construct for Osteonecrosis | Experimental | Biological: MSC construct for OsteonecrosisPatients 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC construct for Osteonecrosis30 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. | Biological | MSC construct for Osteonecrosis |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Related trials for Osteonecrosis of Jaw
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Not yet recruiting
Autologous Platelet Concentrates on the Healing of Extraction Sockets
Medication-related Osteonecrosis of the Jaw
Recruiting
Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
Medication Related Osteonecrosis of the Jaw
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
Not yet recruitingObservational study
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Villanueva San Vicente, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
Francisco J Rodríguez Lozano, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC construct for Osteonecrosis in people with Osteonecrosis of Jaw, run by Red de Terapia Celular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia García Iniesta (+34968381221, nagarini@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of serious adverse events related to the procedure. (time frame: 24 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.