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Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial (BMC2012)

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ClinicalTrials.gov Identifier: NCT02153372
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
LOEWE CGT
Information provided by (Responsible Party):
Ingo Marzi, MD Prof., Goethe University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Humerus Fracture Displaced Proximal Other: BMC2012 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMC2012
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



Primary Outcome Measures :
  1. safety [ Time Frame: at day -1 ]
    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)

  2. safety [ Time Frame: at day 0 ]
    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)

  3. safety [ Time Frame: week 1 post surgery ]
    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)

  4. safety [ Time Frame: week 6 post surgery ]
    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)

  5. safety [ Time Frame: week 12 post surgery ]
    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)


Secondary Outcome Measures :
  1. feasibility [ Time Frame: at day-1 ]
    Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

  2. feasibility [ Time Frame: at day 0 ]
    Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

  3. feasibility [ Time Frame: week 1 post surgery ]
    Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

  4. feasibility [ Time Frame: week 6 post surgery ]
    Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

  5. feasibility [ Time Frame: week 12 post surgery ]
    Analysis of feasibility of isolation and application of BMC, logistic and clinical controls


Other Outcome Measures:
  1. osseous healing by radiologic evaluation [ Time Frame: at day 0 ]
    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

  2. DASH-Score [ Time Frame: at 12 weeks post surgery ]
    testing the function of the shoulder

  3. documentation of concomitant medication and Adverse Events [ Time Frame: at day -1 ]
    analysis of medication and Adverse Events

  4. osseous healing by radiologic evaluation [ Time Frame: week 1 post surgery ]
    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

  5. osseous healing by radiologic evaluation [ Time Frame: week 6 post surgery ]
    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

  6. osseous healing by radiologic evaluation [ Time Frame: week 12 post surgery ]
    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

  7. documentation of concomitant medication and Adverse Events [ Time Frame: day 0 ]
    analysis of medication and Adverse Events

  8. documentation of concomitant medication and Adverse Events [ Time Frame: week 1 ]
    analysis of medication and Adverse Events

  9. documentation of concomitant medication and Adverse Events [ Time Frame: week 6 post surgery ]
    analysis of medication and Adverse Events

  10. documentation of concomitant medication and Adverse Events [ Time Frame: week 12 post surgery ]
    analysis of medication and Adverse Events



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153372


Locations
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Germany
Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital
Frankfurt, Theodor-Stern-Kai 7, Germany, 60590
Sponsors and Collaborators
Goethe University
LOEWE CGT
Investigators
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Principal Investigator: Ingo Marzi, MD Prof. Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

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Responsible Party: Ingo Marzi, MD Prof., head physician, Goethe University
ClinicalTrials.gov Identifier: NCT02153372     History of Changes
Other Study ID Numbers: BMC2012
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Ingo Marzi, MD Prof., Goethe University:
large bone defect, bone marrow-derived mononuclear cells
Additional relevant MeSH terms:
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Humeral Fractures
Fractures, Bone
Wounds and Injuries
Arm Injuries