Condition category
Musculoskeletal Diseases
Date applied
24/09/2009
Date assigned
13/01/2010
Last edited
01/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Prof David Marsh

ORCID ID

Contact details

Professor of Clinical Orthopaedics
Royal National Orthopaedic Hospital
Institute of Orthopaedics and Musculoskeletal Science
Brockley Hill
Stanmore
London
HA7 4LP
United Kingdom

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 measures

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

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

http://www.ucl.ac.uk/joint-rd-unit/

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/02/2016: This trial was abandoned in 2012 due to lack of recruitment.