Cell Therapy by Autologous BMC for Large Bone Defect Repair (BMC2012)
Primary Purpose
Humerus Fracture Displaced Proximal
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
BMC2012
beta-TCP Chronos® Synthes
Sponsored by
About this trial
This is an interventional treatment trial for Humerus Fracture Displaced Proximal focused on measuring large bone defect, bone marrow-derived mononuclear cells
Eligibility 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
Sites / Locations
- Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMC2012 + beta-TCP Chronos® Synthes
beta-TCP Chronos® Synthes
Arm Description
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.
The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02803177
First Posted
June 7, 2016
Last Updated
January 13, 2020
Sponsor
Goethe University
Collaborators
LOEWE CGT
1. Study Identification
Unique Protocol Identification Number
NCT02803177
Brief Title
Cell Therapy by Autologous BMC for Large Bone Defect Repair
Acronym
BMC2012
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
LOEWE CGT
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerus Fracture Displaced Proximal
Keywords
large bone defect, bone marrow-derived mononuclear cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMC2012 + beta-TCP Chronos® Synthes
Arm Type
Experimental
Arm Description
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.
Arm Title
beta-TCP Chronos® Synthes
Arm Type
Placebo Comparator
Arm Description
The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).
Intervention Type
Biological
Intervention Name(s)
BMC2012
Intervention Type
Device
Intervention Name(s)
beta-TCP Chronos® Synthes
Primary Outcome Measure Information:
Title
Secondary dislocation of fracture
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Functional outcome after fixation
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Concomitant medication
Description
Documentation of concomitant medication
Time Frame
day -1
Title
Adverse events
Description
Documentation of adverse events
Time Frame
day -1
Title
Concomitant medication
Description
Documentation of concomitant medication
Time Frame
day 0
Title
Adverse events
Description
Documentation of adverse events
Time Frame
day 0
Title
Concomitant medication
Description
Documentation of concomitant medication
Time Frame
week 1
Title
Adverse events
Description
Documentation of adverse events
Time Frame
week 1
Title
Concomitant medication
Description
Documentation of concomitant medication
Time Frame
week 6
Title
Adverse events
Description
Documentation of adverse events
Time Frame
week 6
Title
Concomitant medication
Description
Documentation of concomitant medication
Time Frame
week 12
Title
Adverse events
Description
Documentation of adverse events
Time Frame
week 12
Title
Degree of bony bridging (percent of defect area) in the bone fracture
Description
Analysis of fracture healing by radiologic evaluation, consolidation, necrosis
Time Frame
week 1
Title
Degree of bony bridging (percent of defect area) in the bone fracture
Description
Analysis of fracture healing by radiologic evaluation, consolidation, necrosis
Time Frame
week 6
Title
Degree of bony bridging (percent of defect area) in the bone fracture
Description
Analysis of fracture healing by radiologic evaluation, consolidation, necrosis
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Marzi, MD Prof.
Organizational Affiliation
Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The researchers will only publish data in their scientific publication
Learn more about this trial
Cell Therapy by Autologous BMC for Large Bone Defect Repair
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