Cell Therapy by Autologous BMC for Large Bone Defect Repair

Humerus Fracture Displaced Proximal Clinical Trial

— BMC2012  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803177
• Other study ID #: BMC2012 Phase IIa
• Status: Completed
• Phase: Phase 2
• Start date: July 2, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Humeral Fractures
• Humerus Fracture Displaced Proximal

Intervention

Biological:
• BMC2012

Device:
• beta-TCP Chronos® Synthes

Locations

Country	Name	City	State
Germany	Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt	Frankfurt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	LOEWE CGT

Country where clinical trial is conducted

Germany, 

Outcome

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