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

NCT ID: NCT02153372

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-09-30

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.

Conditions

Humerus Fracture Displaced Proximal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BMC2012

Intervention Type: OTHER

Interventions

BMC2012

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LOEWE CGT

UNKNOWN

Sponsor Role: collaborator

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Ingo Marzi, MD Prof.

head physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingo Marzi, MD Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

Locations

Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital

Frankfurt, Theodor-Stern-Kai 7, Germany

Countries

Germany

Other Identifiers

BMC2012

Identifier Type: -

Identifier Source: org_study_id