Cell Therapy by Autologous BMC for Large Bone Defect Repair

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Humerus Fracture Displaced Proximal

Intervention / Treatment
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* Biological: BMC2012
* Device: beta-TCP Chronos® Synthes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMC2012 + beta-TCP Chronos® Synthes<br>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. | Biological: BMC2012<br> <br> |
| Placebo Comparator: beta-TCP Chronos® Synthes<br>The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes). | Device: beta-TCP Chronos® Synthes<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary dislocation of fracture | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome after fixation | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large bone defect, bone marrow-derived mononuclear cells