NCT02566681

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

January 30, 2015

Last Update Submit

March 29, 2017

Conditions

Osteonecrosis of Jaw

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • 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)

    24 months from baseline

  • Quality of life, measured by EuroQol-5D.

    24 months from baseline

Study Arms (1)

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

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.

MSC construct for Osteonecrosis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Inability to understand the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Study Officials

  • Victor Villanueva San Vicente, MD

    Hospital Universitario Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

  • Francisco J Rodríguez Lozano, PhD

    Universidad de Murcia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia García Iniesta

CONTACT

+34968381221nagarini@yahoo.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

October 2, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

ES(1)