NCT02153372 - Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial | Crick

Overview

In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

10

Conditions

Humerus Fracture Displaced Proximal

Interventions

BMC2012OTHER

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 major \> 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

Locations (1)

Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital

Frankfurt, Theodor-Stern-Kai 7, Germany