Cell Therapy by Autologous BMC for Large Bone Defect Repair

Phase 2

Completed

• Conditions: Humerus Fracture Displaced Proximal
• Interventions: Biological: BMC2012; Device: beta-TCP Chronos® Synthes

• Registration Number: NCT02803177
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-16
• Study Start: 2016-07-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMC2012 + beta-TCP Chronos® Synthes	BMC2012	The large bone defect will be bridged as per clinical standard, filled with a clinically established scaffold (beta-TCP Chronos® Synthes), and loaded with 1.3 x 10E6 BMC/ml TCP per 1 ml beta-TCP in situ.
beta-TCP Chronos® Synthes	beta-TCP Chronos® Synthes	The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).

Primary Outcome Measures

Name	Time	Method
Secondary dislocation of fracture	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

Secondary Outcome Measures

Name	Time	Method
Functional outcome after fixation	12 weeks	Functional outcome after fixation will be recorded by the Dash-Score at week 12; assessment of safety: all adverse reactions will be recorded and analyzed.

Trial Locations

Locations (1)

Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany