Using autologous mesenchymal stem cells (MSC) to treat human fractures
| ISRCTN | ISRCTN09755245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09755245 |
| Secondary identifying numbers | G0900880 |
- Submission date
- 24/09/2009
- Registration date
- 13/01/2010
- Last edited
- 01/02/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=87
Contact information
Prof David Marsh
Scientific
Scientific
Professor of Clinical Orthopaedics
Royal National Orthopaedic Hospital
Institute of Orthopaedics and Musculoskeletal Science
Brockley Hill, Stanmore
London
HA7 4LP
United Kingdom
Study information
| Study design | Single-blind randomised controlled trial using minimisation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Autologous cell therapy of fracture nonunion - cell phenotype as a predictor of outcome: a single blind randomised controlled trial |
| Study acronym | PACINO |
| Study objectives | 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(s) | Outer North London Research Ethics Committee (REC) pending submission as of 29/09/2009. Planning to submit in October 2009. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2010 |
| Completion date | 31/12/2013 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal National Orthopaedic Hospital
London
HA7 4LP
United Kingdom
HA7 4LP
United Kingdom
Sponsor information
Joint UCLH and UCL Biomedical Research Unit (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Nick McNally
1st Floor, Maples House
Ground Floor, Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
England
United Kingdom
| Website | http://www.ucl.ac.uk/joint-rd-unit/ |
|---|---|
"ROR" |
https://ror.org/03r9qc142 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) - Translational stem cell research programme: Response mode funding (ref: G0900880)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2016: This trial was abandoned in 2012 due to lack of recruitment.
