Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0900880
Study information
Scientific title
Autologous cell therapy of fracture nonunion - cell phenotype as a predictor of outcome: a single blind randomised controlled trial
Acronym
PACINO
Study hypothesis
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?
Ethics approval
Outer North London Research Ethics Committee (REC) pending submission as of 29/09/2009. Planning to submit in October 2009.
Study design
Single-blind randomised controlled trial using minimisation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Tibial nonunion fractures
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2010
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Congenital disorders
2. Pregnant or lactating women
3. Metabolic bone disease or bone active drugs
4. Anticipated problems with maintaining follow-up
Recruitment start date
01/01/2010
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Orthopaedic Hospital
London
HA7 4LP
United Kingdom
Sponsor information
Organisation
Joint UCLH and UCL Biomedical Research Unit (UK)
Sponsor details
c/o Dr Nick McNally
1st Floor
Maples House
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - Translational stem cell research programme: Response mode funding (ref: G0900880)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list