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

Primary Purpose

Humerus Fracture Displaced Proximal

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BMC2012
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMC2012

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)

Secondary Outcome Measures

feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
feasibility
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

Full Information

First Posted
February 13, 2014
Last Updated
May 11, 2016
Sponsor
Goethe University
Collaborators
LOEWE CGT
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1. Study Identification

Unique Protocol Identification Number
NCT02153372
Brief Title
Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial
Acronym
BMC2012
Official Title
Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (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-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.

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 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMC2012
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
BMC2012
Primary Outcome Measure Information:
Title
safety
Description
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)
Time Frame
at day -1
Title
safety
Description
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)
Time Frame
at day 0
Title
safety
Description
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)
Time Frame
week 1 post surgery
Title
safety
Description
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)
Time Frame
week 6 post surgery
Title
safety
Description
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)
Time Frame
week 12 post surgery
Secondary Outcome Measure Information:
Title
feasibility
Description
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Time Frame
at day-1
Title
feasibility
Description
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Time Frame
at day 0
Title
feasibility
Description
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Time Frame
week 1 post surgery
Title
feasibility
Description
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Time Frame
week 6 post surgery
Title
feasibility
Description
Analysis of feasibility of isolation and application of BMC, logistic and clinical controls
Time Frame
week 12 post surgery
Other Pre-specified Outcome Measures:
Title
osseous healing by radiologic evaluation
Description
Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting
Time Frame
at day 0
Title
DASH-Score
Description
testing the function of the shoulder
Time Frame
at 12 weeks post surgery
Title
documentation of concomitant medication and Adverse Events
Description
analysis of medication and Adverse Events
Time Frame
at day -1
Title
osseous healing by radiologic evaluation
Description
Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting
Time Frame
week 1 post surgery
Title
osseous healing by radiologic evaluation
Description
Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting
Time Frame
week 6 post surgery
Title
osseous healing by radiologic evaluation
Description
Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting
Time Frame
week 12 post surgery
Title
documentation of concomitant medication and Adverse Events
Description
analysis of medication and Adverse Events
Time Frame
day 0
Title
documentation of concomitant medication and Adverse Events
Description
analysis of medication and Adverse Events
Time Frame
week 1
Title
documentation of concomitant medication and Adverse Events
Description
analysis of medication and Adverse Events
Time Frame
week 6 post surgery
Title
documentation of concomitant medication and Adverse Events
Description
analysis of medication and Adverse Events
Time Frame
week 12 post surgery

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 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
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 Hospital
City
Frankfurt
State/Province
Theodor-Stern-Kai 7
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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