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CompletedNCT02153372BMC2012Updated May 12, 2016

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

A Phase 1 interventional study of BMC2012 in Humerus Fracture Displaced Proximal, sponsored by Goethe University. Completed at 1 site in Germany. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Goethe University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Humerus Fracture Displaced Proximal

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Keywords

  • large bone defect, bone marrow-derived mononuclear cells
03

In context

Humeral Fractures

175 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.

This study's enrollment of 10 is below the median of 55 across 99 interventional studies indexed under Humeral Fractures.

Browse Humeral Fractures studies →

Lead sponsor

Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • OtherBMC2012
06

What researchers measure

Primary outcomes

  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)

    Time frame: at day -1

  2. 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)

    Time frame: at day 0

  3. 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)

    Time frame: week 1 post surgery

  4. 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)

    Time frame: week 6 post surgery

  5. 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)

    Time frame: week 12 post surgery

Secondary outcomes

  1. feasibility

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

    Time frame: at day-1

  2. feasibility

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

    Time frame: at day 0

  3. feasibility

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

    Time frame: week 1 post surgery

  4. feasibility

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

    Time frame: week 6 post surgery

  5. feasibility

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

    Time frame: week 12 post surgery

Other outcomes

  1. osseous healing by radiologic evaluation

    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

    Time frame: at day 0

  2. DASH-Score

    testing the function of the shoulder

    Time frame: at 12 weeks post surgery

  3. documentation of concomitant medication and Adverse Events

    analysis of medication and Adverse Events

    Time frame: at day -1

  4. osseous healing by radiologic evaluation

    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

    Time frame: week 1 post surgery

  5. osseous healing by radiologic evaluation

    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

    Time frame: week 6 post surgery

  6. osseous healing by radiologic evaluation

    Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting

    Time frame: week 12 post surgery

  7. documentation of concomitant medication and Adverse Events

    analysis of medication and Adverse Events

    Time frame: day 0

  8. documentation of concomitant medication and Adverse Events

    analysis of medication and Adverse Events

    Time frame: week 1

  9. documentation of concomitant medication and Adverse Events

    analysis of medication and Adverse Events

    Time frame: week 6 post surgery

  10. documentation of concomitant medication and Adverse Events

    analysis of medication and Adverse Events

    Time frame: week 12 post surgery

07

Study locations

1 site
  • Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital
    Frankfurt, Theodor-Stern-Kai 7 60590, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02153372
Lead sponsor
Goethe University
Collaborators
LOEWE CGT
Responsible party
Ingo Marzi, MD Prof. (head physician, Goethe University) — Principal investigator
First posted
Jun 3, 2014
Start date
Jul 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
May 12, 2016

Study contacts

Ingo Marzi, MD Prof.
principal investigator · Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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