Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000274976
Ethics application status
Not yet submitted
Date submitted
11/03/2011
Date registered
15/03/2011
Date last updated
27/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Adipose-derived stem cells in patients with knee osetoarthritis: A randomised controlled trial evaluating pain, function and cartillage repair
Scientific title
Adipose-derived stem cells in patients with knee osetoarthritis: A randomised controlled trial evaluating pain, function and cartillage repair
Secondary ID [1] 259772 0
nil
Universal Trial Number (UTN)
U1111-1119-9065
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 261350 0
osteochondral defect 261351 0
stem cell research 261371 0
Condition category
Condition code
Musculoskeletal 259509 259509 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three injections each of 5ml stromal vascular fraction containing adipose-derived stem cells two months apart. Time-points for injections: 1) initial injection, 2) two months following initial injection and 3) four months following initial injection. This results in a total treatment duration of five months.
Intervention code [1] 264201 0
Treatment: Other
Comparator / control treatment
Three injections each of 2ml (16 mg) of Hylan G-F 20 two months apart. Time-points for injections: 1) initial injection, 2) two months following initial injection and 3) four months following initial injection. This results in a total treatment duration of five months.
Control group
Active

Outcomes
Primary outcome [1] 262313 0
Pain measured using 100mm Visual Analogue Score (VAS)
Timepoint [1] 262313 0
Baseline, daily for the first two weeks, weekly for the subsequent two weeks and four and eight weeks, and six and 12 months, following the final injection
Primary outcome [2] 262314 0
Knee Injury and Osteoarthritis Outcome Score
Timepoint [2] 262314 0
Baseline, four and eight weeks, and six and 12 months, following the final injection
Secondary outcome [1] 273509 0
Maximum single leg hop for distance. Participant hops as far as possible and the distance (in cm) from the toe in starting position to heel in landing position is measured by the researcher using a tape measure. The best of three hops is recorded.
Timepoint [1] 273509 0
Baseline, four and eight weeks, and six and 12 months, following the final injection
Secondary outcome [2] 273510 0
Maximum number of knee bends performed in 30 seconds. Participant bends the knee without bending forward from the hip (until they cannot see a line along the toes, equivalent to about 30 degrees of knee flexion) as many times as possible in 30 seconds. Time is recorded using a stopwatch and number of bends are counted by the researcher.
Timepoint [2] 273510 0
Baseline, four and eight weeks, and six and 12 months, following the final injection
Secondary outcome [3] 273511 0
Whole Organ Magnetic Resonance Imaging Score
Timepoint [3] 273511 0
Baseline, six and 12 months, following the final injection

Eligibility
Key inclusion criteria
A diagnosis of OA assessed via the International Cartilage Repair Society guidelines and a visual analogue pain score of greater than 50 out of 100
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No systemic or inflammatory joint disease, no history of crystalline or neuropathic arthropathy, no cancer or other tumour-like lesions, not pregnant or lactating, not drug abusing, no other intra articular lesion in the previous six months, no allergy to any test substance and not immunosuppressed

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruited via a sports medicine clinic and provided with a full medical examination and assessment of the affected knee joint to determine study eligibility. Eligible participants will be allocated to either the control or intervention group by an independent clinic staff member using a central concealed computer randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order concealed allocation of participants into either the control or intervention group will be performed by
simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation). There will be no stratified allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264644 0
University
Name [1] 264644 0
Australian Catholic University
Country [1] 264644 0
Australia
Primary sponsor type
Individual
Name
Kade Paterson
Address
Australian Catholic University, 115 Victoria Pde, Fitzroy VIC 3095
Country
Australia
Secondary sponsor category [1] 263788 0
Individual
Name [1] 263788 0
Dan Bates
Address [1] 263788 0
Lakeside Sports Medicine Centre, Melbourne Sports and Aquatic Centre, Aughtie Drive, Albert Park, VIC 3206
Country [1] 263788 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266644 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 266644 0
Australian Catholic University, Level 5, 250 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [1] 266644 0
Australia
Date submitted for ethics approval [1] 266644 0
04/03/2011
Approval date [1] 266644 0
Ethics approval number [1] 266644 0

Summary
Brief summary
Knee osteoarthritis (OA) is a progressive degenerative condition of articular cartilage and subchondral bone that leads to significant physical and psychological disability, and adversely affects daily function and quality of life. Current treatment of knee OA is associated with limitations and side effects that restrict their ability to effectively treat the symptoms of the condition and stop its progression.

Recent research has demonstrated that Human adipose-derived stem cells (ADSCs) are safe for use in Humans and can differentiate into cartilage and bone, suggesting a potential treatment in osteoarthritis. This study aims to assess the changes in pain, cartilage and bone appearance, activity levels and lower extremity functional ability of patients with knee OA following intra-articular ADSC injection compared to usual treatment of Hylan G-F 20 (Synvisc [Registered Trademark]).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32336 0
Dr Kade Paterson
Address 32336 0
Centre for Health, Exercise & Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
Country 32336 0
Australia
Phone 32336 0
+61 3 8344 0425
Fax 32336 0
+61 3 8344 3771
Email 32336 0
[email protected]
Contact person for public queries
Name 15583 0
Dr Kade Paterson
Address 15583 0
Centre for Health, Exercise & Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
Country 15583 0
Australia
Phone 15583 0
+61 3 8344 0425
Fax 15583 0
+61 3 8344 3771
Email 15583 0
[email protected]
Contact person for scientific queries
Name 6511 0
Dr Kade Paterson
Address 6511 0
Centre for Health, Exercise & Sports Medicine
Department of Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne, Victoria, 3010
Country 6511 0
Australia
Phone 6511 0
+61 3 8344 0425
Fax 6511 0
+61 3 8344 3771
Email 6511 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.