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Autologous Stem Cell Therapy for Fracture Non-union Healing

NCT02177565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-03-11

No results posted yet for this study

Summary

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Conditions

  • Non-union of Fractures

Interventions

BIOLOGICAL

carrier plus in vitro expanded autologous BMSCs

The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

Sponsors & Collaborators

  • Keele University

    collaborator OTHER

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    lead OTHER_GOV

Principal Investigators

  • James Richardson, FRCS MD · Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02177565 on ClinicalTrials.gov