Last updated on May 2020

Cell Therapy by Autologous BMC for Large Bone Defect Repair

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Humerus Fracture Displaced Proximal
  • Age: Between 50 - 90 Years
  • Gender: Male or Female

Inclusion Criteria:

  • patients aged between 50. and 90. years with proximal humerus fractures
  • indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):
  • 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 tuberculum majus > 5 mm
  • negative pregnancy test of premenopausal women
  • signed informed consent for surgery and participation in the clinical trial

Exclusion Criteria:

  • contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing
  • dislocation fracture
  • known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
  • pathologic fractures caused by other underlying diseases
  • fracture-induced nerve damage
  • tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
  • known hypersensibility against components of the transplant
  • participation in a clinical trial during the last 3 months prior to this study

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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