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Completed

NCT Number: NCT02177565

Autologous Stem Cell Therapy for Fracture Non-union Healing

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

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Key information

Conditions

Non-union of Fractures Fractures, Bone Wounds and Injuries

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Jones & Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

About this study

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An established non-union according to the US Food & Drug Administration criteria14.
  • Non-union following fracture of tibia or femur suitable for synthetic bone grafting.

Exclusion criteria

  • Skeletal immaturity.
  • Pregnant or breast-feeding.
  • Non-union following pathological fractures.
  • Positive to Hepatitis B, Hepatitis-C or HIV.
  • Infection during BMSC culture.

Treatment and study plan

carrier plus in vitro expanded autologous BMSCs

Biological

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

Primary outcomes

  1. Radiological assessment of new callus and fracture bridging

    Time frame: 12 months

    The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.

Secondary outcomes

  1. EQ-5D

    Time frame: 12 months

    Change in EQ-5D index at 1 year was used as secondary outcome measures.

Sponsors and collaborators

Lead sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Other Gov

Collaborators

  • Keele University

Registry information

Important dates

Study start
2000
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2014
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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