Investigation of cell based therapy by implanted bone marrow-derived mononuclear cells for bone augmentation on osteosynthesis of proximal humeral fractures
Conditions
Interventions
Product Name: Bone marrow-derived mononuclear cells (BMC)
Pharmaceutical Form: Implantation suspension
Sponsors
Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged from =50 to =90 with proximal humeral fracture • Indication for open reposition and internal stabilization using a proximal fixed-angle plate for humerus (PHILOS®, Synthes, Oberdorf, Schweiz) • 2-, 3- or 4-fragment fracture according to Neer • Dislocation of =10 mm between fragments and/or • Angle of =45° between fragments and/or • Dislocation of tuberkulum majus of =5 mm • negative pregnancy test of premänopausal women • Ability to understand the content, consequence and improtance of the clinical trial • Signed informed consent form for surgery and participation in the clinical trial 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 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47
Exclusion criteria
Exclusion criteria: • Contraindications against administration of IMP are pregnancy and breast-feeding • Dislocation fracture • Known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression) • Patients not qualified for legal acts • Pathologic fractures caused by underlying diseases • Fracture-induced nerve damage • Tumor diseases with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases • Participation in a clinical trial during the last 3 months prior inclusion to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Osseous healing of fracture after 12 weeks by radiological evaluation: • Frequency of secondary dislocation of result of reposition (varus dislocation of = 20° of head/shaft angle a, ?a);Secondary Objective: a) Osseous healing of fracture • osseous healing of fracture (consolidation, necrosis) • secondary perforation of bone screw • quantitative evaluation of ?a b) With regards to tolerability / side effects: • Morbidity extraction • local infection / side effects (inflammation, wound healing disorder), • systemic infection / side effects (BB, CRP, IL-6, PCT), • Fever (>38,5°C) longer than 2 days c) Shoulder function: DASH-Score (12 weeks post-op) d) Registration of concomitant medication (visits 1-5) and adverse events (visits 2-5);Primary end point(s): a)Osseous healing of fracture after 12 weeks by radiological evaluation: • Frequency of secondary dislocation of result of reposition (varus dislocation of = 20° of head/shaft angle a, ?a) ;Timepoint(s) of evaluation of this end point: 12 weeks post-op | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are: a) Osseous healing of fracture • osseous healing of fracture (consolidation, necrosis) • secondary perforation of bone screw • quantitative evaluation of ?a b) With regards to tolerability / side effects: • Morbidity extraction • local infection / side effects (inflammation, wound healing disorder), • systemic infection / side effects (BB, CRP, IL-6, PCT), • Fever (>38,5°C) longer than 2 days c) Shoulder function: DASH-Score (12 weeks post-op) d) Registration of concomitant medication (visits 1-5) and adverse events (visits 2-5) ;Timepoint(s) of evaluation of this end point: a) visits 1 to 5 b) visit 5, 12 weeks post-op c) concomitant medication (visits 1-5) and adverse events (visits 2-5) | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Ingo Marzi
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Frankfurt, Goethe-Universität
Outcome results
None listed