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Completed

NCT Number: NCT02153372

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

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.

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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 1

Primary location

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

Frankfurt, Theodor-Stern-Kai 7, 60590, 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 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

Treatment and study plan

BMC2012

Other

Primary outcomes

  1. safety

    Time frame: at day -1

    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)

  2. safety

    Time frame: at day 0

    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)

  3. safety

    Time frame: week 1 post surgery

    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)

  4. safety

    Time frame: week 6 post surgery

    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)

  5. safety

    Time frame: week 12 post surgery

    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 outcomes

  1. feasibility

    Time frame: at day-1

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

  2. feasibility

    Time frame: at day 0

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

  3. feasibility

    Time frame: week 1 post surgery

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

  4. feasibility

    Time frame: week 6 post surgery

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

  5. feasibility

    Time frame: week 12 post surgery

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

Other outcomes

  1. osseous healing by radiologic evaluation

    Time frame: at day 0

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

  2. DASH-Score

    Time frame: at 12 weeks post surgery

    testing the function of the shoulder

  3. documentation of concomitant medication and Adverse Events

    Time frame: at day -1

    analysis of medication and Adverse Events

  4. osseous healing by radiologic evaluation

    Time frame: week 1 post surgery

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

  5. osseous healing by radiologic evaluation

    Time frame: week 6 post surgery

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

  6. osseous healing by radiologic evaluation

    Time frame: week 12 post surgery

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

  7. documentation of concomitant medication and Adverse Events

    Time frame: day 0

    analysis of medication and Adverse Events

  8. documentation of concomitant medication and Adverse Events

    Time frame: week 1

    analysis of medication and Adverse Events

  9. documentation of concomitant medication and Adverse Events

    Time frame: week 6 post surgery

    analysis of medication and Adverse Events

  10. documentation of concomitant medication and Adverse Events

    Time frame: week 12 post surgery

    analysis of medication and Adverse Events

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • LOEWE CGT

Registry information

Official study title

Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures

Acronym: BMC2012

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2014
Registry last updated
May 12, 2016

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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