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

Humerus Fracture Displaced Proximal Clinical Trial

— BMC2012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153372
• Other study ID #: BMC2012
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2014
• Last updated: May 11, 2016
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Humeral Fractures
• Humerus Fracture Displaced Proximal

Intervention

Other:
• BMC2012

Locations

Country	Name	City	State
Germany	Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital	Frankfurt	Theodor-Stern-Kai 7

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	osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	at day 0	No
Other	DASH-Score	testing the function of the shoulder	at 12 weeks post surgery	No
Other	documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	at day -1	Yes
Other	osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 1 post surgery	No
Other	osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 6 post surgery	No
Other	osseous healing by radiologic evaluation	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting	week 12 post surgery	No
Other	documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	day 0	Yes
Other	documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 1	Yes
Other	documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 6 post surgery	Yes
Other	documentation of concomitant medication and Adverse Events	analysis of medication and Adverse Events	week 12 post surgery	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	at day-1	No
Secondary	feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	at day 0	No
Secondary	feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 1 post surgery	No
Secondary	feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 6 post surgery	No
Secondary	feasibility	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls	week 12 post surgery	No