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

Goethe University1 site in 1 country55 target enrollmentJuly 2, 2016

ConditionsHumerus Fracture Displaced Proximal

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Humerus Fracture Displaced Proximal
Sponsor: Goethe University
Enrollment: 55
Locations: 1
Primary Endpoint: Secondary dislocation of fracture
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In the present phase-II clinical trial the researchers investigate efficacy and proof of concept of the 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.

Registry

clinicaltrials.gov

Start Date

July 2, 2016

End Date

December 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Goethe University

Responsible Party

Principal Investigator

Ingo Marzi, MD Prof.

head physician

Goethe University

Eligibility Criteria

Inclusion Criteria

•patients aged between
•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

Outcomes

Primary Outcomes

Secondary dislocation of fracture

Time Frame: 12 weeks

Secondary dislocation is diagnosed on plain radiographs, if more than 20° varus collapse of the humeral head fragment in relation to the humeral shaft and / or screw penetration through the humeral head is detected