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

Phase 1

Completed

• Conditions: Humerus Fracture Displaced Proximal
• Interventions: Other: BMC2012

• Registration Number: NCT02153372
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMC2012	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.

Primary Outcome Measures

Name	Time	Method
safety	week 12 post surgery	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)

Secondary Outcome Measures

Name	Time	Method
feasibility	week 12 post surgery	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

Trial Locations

Locations (1)

Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital; 🇩🇪 Frankfurt, Theodor-Stern-Kai 7, Germany