Cell Therapy by Autologous BMC for Large Bone Defect Repair (BMC2012)

Goethe University

Status and phase: Completed; Phase 2

Conditions: Humerus Fracture Displaced Proximal

Treatments: Biological: BMC2012; Device: beta-TCP Chronos® Synthes

Study type: Interventional

Funder types: Other

Identifiers

NCT02803177

BMC2012 Phase IIa

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups, including a placebo group

BMC2012 + beta-TCP Chronos® Synthes

Experimental group

Description:

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.

Treatment:

Biological: BMC2012

beta-TCP Chronos® Synthes

Placebo Comparator group

Description:

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

Treatment:

Device: beta-TCP Chronos® Synthes