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Cell Therapy by Autologous BMC for Large Bone Defect Repair

NCT02803177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-01-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

BMC2012

DEVICE

beta-TCP Chronos® Synthes

Sponsors & Collaborators

  • LOEWE CGT

    collaborator UNKNOWN

  • Goethe University

    lead OTHER

Principal Investigators

  • Ingo Marzi, MD Prof. · Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-02
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02803177 on ClinicalTrials.gov