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Cell Therapy by Autologous BMC for Large Bone Defect Repair (BMC2012)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02803177
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
LOEWE CGT
Information provided by (Responsible Party):
Ingo Marzi, MD Prof., 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.

Condition or disease Intervention/treatment Phase
Humerus Fracture Displaced Proximal Biological: BMC2012 Device: beta-TCP Chronos® Synthes Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2, 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMC2012 + beta-TCP Chronos® Synthes
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
Placebo Comparator: 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).
Device: beta-TCP Chronos® Synthes



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Functional outcome after fixation [ Time Frame: 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.


Other Outcome Measures:
  1. Concomitant medication [ Time Frame: day -1 ]
    Documentation of concomitant medication

  2. Adverse events [ Time Frame: day -1 ]
    Documentation of adverse events

  3. Concomitant medication [ Time Frame: day 0 ]
    Documentation of concomitant medication

  4. Adverse events [ Time Frame: day 0 ]
    Documentation of adverse events

  5. Concomitant medication [ Time Frame: week 1 ]
    Documentation of concomitant medication

  6. Adverse events [ Time Frame: week 1 ]
    Documentation of adverse events

  7. Concomitant medication [ Time Frame: week 6 ]
    Documentation of concomitant medication

  8. Adverse events [ Time Frame: week 6 ]
    Documentation of adverse events

  9. Concomitant medication [ Time Frame: week 12 ]
    Documentation of concomitant medication

  10. Adverse events [ Time Frame: week 12 ]
    Documentation of adverse events

  11. Degree of bony bridging (percent of defect area) in the bone fracture [ Time Frame: week 1 ]
    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis

  12. Degree of bony bridging (percent of defect area) in the bone fracture [ Time Frame: week 6 ]
    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis

  13. Degree of bony bridging (percent of defect area) in the bone fracture [ Time Frame: week 12 ]
    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis



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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 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

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): NCT02803177


Locations
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Germany
Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
Frankfurt, Hessen, Germany, 60528
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: NCT02803177    
Other Study ID Numbers: BMC2012 Phase IIa
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The researchers will only publish data in their scientific publication
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