BMC2012, Cell based therapy by implanted bone marrow-derived mononuclear cells (BMC) for bone augmentation of plate-stabilized proximal humeral fractures - a randomized, open, multicentric study - phase IIa - Cell based therapy by implanted BMC for bone augmentation of humeral fractures, Phase IIa

Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität0 个研究点目标入组 57 人开始时间: 2015年10月15日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•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

•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

发起方

Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität