Diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus) status delayed union (after 3 months) treated by standard care procedures
Conditions
Interventions
Product Name: Mesenchymal stem cells and microporous Bi-phasic calcium phosphate (MBCP+)
Product Code: Behandling, Ortho
Pharmaceutical Form: Granules
Sponsors
University of Bergen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are: - Age 18 to 65, both sexes - Traumatic isolated closed or open Gustilo-Anderson I, II or IIIa humerus, tibial, ulna or femur - diaphyseal or metaphysodiaphyseal fracture with a bone loss of 2-10 cm. - Able to provide informed consent, and signed informed consent - Patients (by themselves) should have medical health care coverage to be included in a research study. - Able to understand and accept the study constraints To further standardize the inclusion, patients to be included will be those that alternatively would have received bone autograft and/or BMPs, thus avoiding (excluding) segmental defect patients to be treated with large allografts. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The non-inclusion criteria are: - Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control - Participation in another therapeutic trial in the previous 3 months - Delayed union or non-union related to iatrogeny - Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc) - Vascular or neural injury - Other fractures causing interference with weight bearing - Infection: skin, soft-tissue, bone or any remote infection (dental, pulmonary, gynecological) - Visceral injuries of diseases interfering with callus formation - (craneoencephalic trauma, etc.) - History of bone harvesting on iliac crest contraindicating bone-marrow aspiration - Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion - History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR) - Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility. - Impossibility to meet at the appointments for the follow up - Insulin dependent diabetes - Obesity (BMI > 30) - Autoimmune inflammatory disease - Current treatment by biphosphonate or stopped in the three months prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of apposition of biomaterial with autologous MSCs at the fracture site.;Secondary Objective: To obtain consolidation, without increasing the complication rate, of diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus) status delayed union (after 3 months) treated by standard care procedures plus apposition of biomaterial with autologous MSCs at the fracture site.;Primary end point(s): Proven bone healing ;Timepoint(s) of evaluation of this end point: 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Amount of radiological callus at 12 weeks, and 26 weeks. - Clinical consolidation at weeks 12, 24. - No reoperation done or scheduled at 26 weeks. - Changes in serum levels of bone turnover markers (in a centralized laboratory) at 6, 12 and 26 weeks after treatment: the following markers will be evaluated by immunoenzymatic assays on serum samples on all recruited patients ;Timepoint(s) of evaluation of this end point: 6, 12 and 24 weeks | — |
Countries
Norway
Contacts
Public ContactCecilie Gjerde
University of Bergen, Faculty of Medicin, Department of Clinical Dentistry
Outcome results
None listed