Cell Therapy by Autologous BMC for Large Bone Defect Repair (BMC2012)

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

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.

Study Overview

• Status: Completed
• Conditions: Humerus Fracture Displaced Proximal
• Intervention / Treatment: Biological: BMC2012; Device: beta-TCP Chronos® Synthes

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60528
      • Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BMC2012 + beta-TCP Chronos® Synthes; The large bone defect will be bridged as per clinical standard, filled with a clinically established scaffold (beta-TCP Chronos® Synthes), and loaded with 1.3 x 10E6 BMC/ml TCP per 1 ml beta-TCP in situ.	Biological: BMC2012
PLACEBO_COMPARATOR: beta-TCP Chronos® Synthes; The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).	Device: beta-TCP Chronos® Synthes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary dislocation of fracture	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome after fixation	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.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concomitant medication	Documentation of concomitant medication	day -1
Adverse events	Documentation of adverse events	day -1
Concomitant medication	Documentation of concomitant medication	day 0
Adverse events	Documentation of adverse events	day 0
Concomitant medication	Documentation of concomitant medication	week 1
Adverse events	Documentation of adverse events	week 1
Concomitant medication	Documentation of concomitant medication	week 6
Adverse events	Documentation of adverse events	week 6
Concomitant medication	Documentation of concomitant medication	week 12
Adverse events	Documentation of adverse events	week 12
Degree of bony bridging (percent of defect area) in the bone fracture	Analysis of fracture healing by radiologic evaluation, consolidation, necrosis	week 1
Degree of bony bridging (percent of defect area) in the bone fracture	Analysis of fracture healing by radiologic evaluation, consolidation, necrosis	week 6
Degree of bony bridging (percent of defect area) in the bone fracture	Analysis of fracture healing by radiologic evaluation, consolidation, necrosis	week 12

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: LOEWE CGT

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2016
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The researchers will only publish data in their scientific publication