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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02153372

Acronym

BMC2012

Enrollment

Registered

2014-06-03

Start date

2013-07-31

Completion date

2014-09-30

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humerus Fracture Displaced Proximal

Keywords

large bone defect, bone marrow-derived mononuclear cells

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.

Interventions

OTHERBMC2012

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

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 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

Design outcomes

Primary

Measure	Time frame	Description
safety	at day -1	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

Measure	Time frame	Description
feasibility	at day-1	Analysis of feasibility of isolation and application of BMC, logistic and clinical controls

Other

Measure	Time frame	Description
osseous healing by radiologic evaluation	at day 0	Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting
DASH-Score	at 12 weeks post surgery	testing the function of the shoulder
documentation of concomitant medication and Adverse Events	at day -1	analysis of medication and Adverse Events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026