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ISRCTN
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ISRCTN09755245
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ClinicalTrials.gov identifier
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Public title
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Using autologous mesenchymal stem cells (MSC) to treat human fractures
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Scientific title
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Autologous cell therapy of fracture nonunion - cell phenotype as a predictor of outcome: a single blind randomised controlled trial
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Acronym
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PACINO
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Serial number at source
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G0900880
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Study hypothesis
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The study questions are:
1. Do culture-expanded, autologous mesenchymal stem cells (MSC) stimulate healing of nonunions more effectively than unmodified bone marrow?
2. Does the magnitude of the regenerative response correlate with any identifiable phenotypic features of the implanted cells?
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Lay summary
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http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=87
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Ethics approval
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Outer North London Research Ethics Committee (REC) pending submission as of 29/09/2009. Planning to submit in October 2009.
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Study design
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Single blind randomised controlled trial using minimisation
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Tibial nonunion fractures
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Participants - inclusion criteria
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1. Skeletally mature patients undergoing segmental excision of the tibia for nonunion followed by distraction osteogenesis and bone transport
2. Male and female patients
3. Over 18 years old with no upper age limit
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Participants - exclusion criteria
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1. Congenital disorders
2. Pregnant or lactating women
3. Metabolic bone disease or bone active drugs
4. Anticipated problems with maintaining follow-up
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Anticipated start date
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01/01/2010
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Anticipated end date
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31/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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The standard treatment involves microdrilling holes across the docking site into which the patients own bone marrow is injected. This will be the treatment in the control arm of the trial. The study intervention will be the injection of the patients own mesenchymal stem cells (MSCs) into the microdrilled holes. Patients will receive one dose of either bone marrow or MSCs depending on whether they are in the control or intervention arm of the trial respectively. Treament is a single dose of 30 million MSCs at the docking site, the follow-up is for one year post-docking.
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Primary outcome measure(s)
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Change in bone mineral content (BMC) in a defined region of interest (ROI) around the docking site between 0 - 12 weeks after implantation, derived from computed tomography (CT) scans.
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Secondary outcome measure(s)
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Imaging-based:
1. X-Rays: bridging of 3 out of 4 cortices
2. Finite Element Analysis (FEA)
3. Reliable Unwrapping Susceptibility Technique (RUST) scores
The first antero-posterior (AP) and lateral radiographs will be taken prior to the segmental excision and after enrolment and then at 2 weekly intervals for 12 weeks with 3 radiographs in addition to standard care and then in line with standard care until week 52.
Clinical outcomes:
4. Short-form Musculoskeletal Function Assessment (SMFA)
5. Pain (Visual Analogue Scale [VAS])
6. Quality of life (36-item Short Form Health Survey [SF36]) and the need for re-operation
Patients will be asked to complete SF36 and SMFA questionnaires at 2, 12 and 25 weeks and VAS pain scores will be given in line with standard care.
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Sources of funding
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Medical Research Council (MRC) (UK) - Translational stem cell research programme: Response mode funding (ref: G0900880)
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Trial website
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Publications
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Contact name
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Prof
David
Marsh
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Address
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Professor of Clinical Orthopaedics
Royal National Orthopaedic Hospital
Institute of Orthopaedics and Musculoskeletal Science
Brockley Hill, Stanmore
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City/town
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London
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Zip/Postcode
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HA7 4LP
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Country
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United Kingdom
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Sponsor
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Joint UCLH and UCL Biomedical Research Unit (UK)
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Address
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c/o Dr Nick McNally
1st Floor, Maples House
Ground Floor, Rosenheim Wing
25 Grafton Way
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City/town
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London
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Zip/Postcode
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WC1E 6DB
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Country
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United Kingdom
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Sponsor website:
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http://www.ucl.ac.uk/joint-rd-unit/
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Date applied
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24/09/2009
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Last edited
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28/06/2011
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Date ISRCTN assigned
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13/01/2010
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