Cell Therapy by Autologous BMC for Large Bone Defect Repair

NCT ID: NCT02803177

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-02
• Study Completion Date: 2019-12-31

Brief 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.

Conditions

Humerus Fracture Displaced Proximal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BMC2012 + beta-TCP Chronos® Synthes

The large bone defect will be bridged as per clinical standard, filled with a clinically established scaffold (beta-TCP Chronos® Synthes), and loaded with 1.3 x 10E6 BMC/ml TCP per 1 ml beta-TCP in situ.

Group Type: EXPERIMENTAL

BMC2012

Intervention Type: BIOLOGICAL

beta-TCP Chronos® Synthes

The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).

Group Type: PLACEBO_COMPARATOR

beta-TCP Chronos® Synthes

Intervention Type: DEVICE

Interventions

BMC2012

Intervention Type: BIOLOGICAL

beta-TCP Chronos® Synthes

Intervention Type: DEVICE

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 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

• 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, Frankfurt

Frankfurt am Main, Hesse, Germany

Countries

Germany

Other Identifiers

BMC2012 Phase IIa

Identifier Type: -

Identifier Source: org_study_id