Clinical trial NCT02153372: Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial
Official title: Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Humerus Fracture Displaced Proximal
Keywords: large bone defect, bone marrow-derived mononuclear cells
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: LOEWE CGT
First posted: 2014-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: safety
timeFrame: at day -1
measure: safety
timeFrame: at day 0
measure: safety
timeFrame: week 1 post surgery
measure: safety
timeFrame: week 6 post surgery
measure: safety
timeFrame: week 12 post surgery
Secondary outcomes:
measure: feasibility
timeFrame: at day-1
measure: feasibility
timeFrame: at day 0
measure: feasibility
timeFrame: week 1 post surgery
measure: feasibility
timeFrame: week 6 post surgery
measure: feasibility
timeFrame: week 12 post surgery
Other outcomes:
measure: osseous healing by radiologic evaluation
timeFrame: at day 0
measure: DASH-Score
timeFrame: at 12 weeks post surgery
measure: documentation of concomitant medication and Adverse Events
timeFrame: at day -1
measure: osseous healing by radiologic evaluation
timeFrame: week 1 post surgery
measure: osseous healing by radiologic evaluation
timeFrame: week 6 post surgery
measure: osseous healing by radiologic evaluation
timeFrame: week 12 post surgery
measure: documentation of concomitant medication and Adverse Events
timeFrame: day 0
measure: documentation of concomitant medication and Adverse Events
timeFrame: week 1
measure: documentation of concomitant medication and Adverse Events
timeFrame: week 6 post surgery
measure: documentation of concomitant medication and Adverse Events
timeFrame: week 12 post surgery
Locations:
city: Frankfurt
country: Germany
facility: Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital
state: Theodor-Stern-Kai 7
Study officials:
affiliation: Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt
name: Ingo Marzi, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References: