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

Study Overview
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Brief Summary
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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.

Official Title
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Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures

Conditions
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Humerus Fracture Displaced Proximal

Intervention / Treatment
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* Other: BMC2012


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 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMC2012<br>The large bone defect was then be bridged as per clinical standard, filled with a clinically established scaffold (ß-TCP), and 1.3 x106/ml BMC were loaded per 1 ml ß-TCP in situ. | Other: BMC2012<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | at day -1 | 
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | at day 0 | 
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 1 post surgery | 
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 6 post surgery | 
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 12 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | at day-1 | 
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | at day 0 | 
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 1 post surgery | 
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 6 post surgery | 
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 12 post surgery | 

 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