Autologous Stem Cell Therapy for Fracture Non-union Healing

March 9, 2020 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Shropshire
      • Oswestry, Shropshire, United Kingdom, SY10 7AG
        • Robert Jones & Agnes Hunt Orthopaedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: carrier plus BMSCs
carrier plus in vitro expanded autologous BMSCs
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
PLACEBO_COMPARATOR: carrier alone (control).
Carrier alone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: 12 months
Change in EQ-5D index at 1 year was used as secondary outcome measures.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborators

Keele University

Investigators

  • Principal Investigator: James Richardson, FRCS MD, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (ESTIMATE)

June 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL1 254
  • Issuing Organisation (OTHER: Robert Jones & Agnes Hunt Orthopaedic Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-union of Fractures

Clinical Trials on carrier plus in vitro expanded autologous BMSCs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe