Status unknownNCT02566681MSC/ONMUpdated Mar 30, 2017

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 interventional study of MSC construct for Osteonecrosis in Osteonecrosis of Jaw, sponsored by Red de Terapia Celular. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Red de Terapia Celular · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years to 85 Years
Sex: All

Study 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.

Conditions studied

Osteonecrosis of Jaw

Browse trials for

Osteonecrosis 184

In context

Osteonecrosis

184 studies on the registry are indexed under Osteonecrosis; 33 are open to participants now.

This study's planned enrollment of 10 is below the median of 51 across 98 interventional studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

Red de Terapia Celular is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (estimated)

Study arms

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

Interventions

BiologicalMSC 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.

What researchers measure

Primary outcomes

Rate of serious adverse events related to the procedure.
Apparition of Bone ischemic events. Neoformations.
Time frame: 24 months from baseline
Rate of non-serious adverse events related to the procedure.
Local infection of the surgical wound. Pseudarthrosis implant. Allergic reactions.
Time frame: 24 months from baseline

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

Study locations

1 of 1 sites recruiting

Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia 30120, Spain
- Natalia García Iniesta · Contact · nagarini@yahoo.es · +34968381221
- Victor Villanueva San Vicente, MD · Principal investigator
- Francisco J Rodríguez Lozano, PhD · Principal 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 · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02566681
Lead sponsor: Red de Terapia Celular
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
First posted: Oct 2, 2015
Start date: Sep 2015
Primary completion: Dec 2018 (estimated)
Completion: Dec 2018 (estimated)
Last update: Mar 30, 2017

Study contacts

Natalia García Iniesta

Contact

nagarini@yahoo.es

+34968381221

Victor Villanueva San Vicente, MD

principal investigator · Hospital Universitario Virgen de la Arrixaca

Francisco J Rodríguez Lozano, PhD

principal investigator · Universidad de Murcia

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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