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Completed

NCT Number: NCT02803177

Cell Therapy by Autologous BMC for Large Bone Defect Repair

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.

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Key information

Conditions

Humerus Fracture Displaced Proximal

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

Frankfurt am Main, Hesse, 60528, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMC2012

Biological

beta-TCP Chronos® Synthes

Device

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • LOEWE CGT

Registry information

Official study 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

Acronym: BMC2012

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2016
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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