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

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

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.

Study Overview

• Status: Completed
• Conditions: Humerus Fracture Displaced Proximal
• Intervention / Treatment: Other: BMC2012

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at day -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)	at day 0
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)	week 1 post surgery
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)	week 6 post surgery
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)	week 12 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	at day-1
feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	at day 0
feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 1 post surgery
feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 6 post surgery
feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 12 post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	at day 0
DASH-Score	testing the function of the shoulder	at 12 weeks post surgery
documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	at day -1
osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 1 post surgery
osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 6 post surgery
osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 12 post surgery
documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	day 0
documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 1
documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 6 post surgery
documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 12 post surgery

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: LOEWE CGT

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: large bone defect, bone marrow-derived mononuclear cells
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Humeral Fractures
• Other Study ID Numbers: BMC2012