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Clinical Trials/EUCTR2015-001820-51-DE
EUCTR2015-001820-51-DE
Active, not recruiting
Phase 1

BMC2012, Cell based therapy by implanted bone marrow-derived mononuclear cells (BMC) for bone augmentation of plate-stabilized proximal humeral fractures - a randomized, open, multicentric study - phase IIa - Cell based therapy by implanted BMC for bone augmentation of humeral fractures, Phase IIa

Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität0 sites57 target enrollmentOctober 15, 2015
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ConditionsInvestigation of cell based therapy by implanted bone marrow-derived mononuclear cells for bone augmentation on osteosynthesis of proximal humeral fracturesTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Investigation of cell based therapy by implanted bone marrow-derived mononuclear cells for bone augmentation on osteosynthesis of proximal humeral fractures
Sponsor
Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität
Enrollment
57
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 15, 2015
End Date
January 7, 2020
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dekan der medizinischen Fakultät, Universitätsklinikum Frankfurt, Goethe-Universität

Eligibility Criteria

Inclusion Criteria

  • •Patients aged from \=50 to \=90 with proximal humeral fracture
  • •Indication for open reposition and internal stabilization using a proximal fixed\-angle plate for humerus (PHILOS®, Synthes, Oberdorf, Schweiz)
  • •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 tuberkulum majus of \=5 mm
  • •negative pregnancy test of premänopausal women
  • •Ability to understand the content, consequence and improtance of the clinical trial
  • •Signed informed consent form for surgery and participation in the clinical trial
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •Contraindications against administration of IMP are pregnancy and breast\-feeding
  • •Dislocation fracture
  • •Known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
  • •Patients not qualified for legal acts
  • •Pathologic fractures caused by underlying diseases
  • •Fracture\-induced nerve damage
  • •Tumor diseases with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
  • •Participation in a clinical trial during the last 3 months prior inclusion to this study

Outcomes

Primary Outcomes

Not specified

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