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

Phase 1

• Conditions: Investigation of cell based therapy by implanted bone marrow-derived mononuclear cells for bone augmentation on osteosynthesis of proximal humeral fractures; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2015-001820-51-DE
• Lead Sponsor: Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Study Completion: 2020-01-07
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified