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Trial registered on ANZCTR


Registration number
ACTRN12611001046998
Ethics application status
Approved
Date submitted
4/10/2011
Date registered
5/10/2011
Date last updated
3/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Osteoarthritis Stem Cell Advanced Research Study
Scientific title
A Randomised Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of Autologous Non-Expanded Adipose Derived Stem Cells In The Treatment Of Knee Osteoarthritis
Secondary ID [1] 273164 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 278915 0
Condition category
Condition code
Musculoskeletal 279092 279092 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 5mL injection into the knee joint space of cell suspension, which includes autologous adipose derived stem cells and sterile normal saline. On average 50million cells are injected.

Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 80 minutes). The fat is processed on-site to isolate the cells (this process takes up to 2 hours). The suspension of stem cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
Intervention code [1] 269494 0
Treatment: Other
Comparator / control treatment
A single 5mL injection into the knee joint space of sterile normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 279730 0
Primary Outcome 1: Change in ICOAP pain scale
Timepoint [1] 279730 0
at 4, 12 & 24 weeks after intervention
Primary outcome [2] 279731 0
Primary Outcome 2: Percentage of patients achieving OMERACT-OARSI responder criteria.
Timepoint [2] 279731 0
at 4, 12 & 24 weeks after intervention
Secondary outcome [1] 294323 0
Secondary Outcome 1: Analgesic use. A daily diary is completed by the patient to record analgesic use.
Timepoint [1] 294323 0
at 1, 4, 12 and 24 weeks
Secondary outcome [2] 294324 0
Secondary Outcome 2: Change in KOOS disability scale
Timepoint [2] 294324 0
at 12 and 24 weeks
Secondary outcome [3] 294325 0
Secondary Outcome 3: Australian Assessment of Quality of Life Index
Timepoint [3] 294325 0
at 12 and 24 weeks

Eligibility
Key inclusion criteria
Aged over 40 years
Knee pain on most days of the last month
OARSI Grade 1 or 2 with joint space narrowing in either medial or lateral compartments
or
Osteophyte grade 2 or 3 in medial or lateral compartment without Joint Space Narrowing
Symptomatic Knee Osteoarthritis as measured by a pain score of at least 42 on the Numerical Rating Scale.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or inability to give informed consent
Pregnancy or lactation
OARSI Grade 3 or above changes in either knee
Planned knee or hip joint replacement surgery
Positive blood test to HIV, HBV or HCV at Screening Visit
Positive nasal or groin swab for MRSA at Screening Visit
More than 2mm space in the knee joint on X-Ray at Screening Visit
Subjects with metal implants such as knee, hip or aortic valve prosthetics
Any clinically significant condition(s) that in the opinion of the investigator may compromise safety or compliance, interfere with evaluation or preclude completion of the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269975 0
Commercial sector/Industry
Name [1] 269975 0
Regeneus Pty Ltd
Address [1] 269975 0
77 Ridge St Gordon NSW 2072
Country [1] 269975 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Regeneus Pty Ltd
Address
77 Ridge St Gordon NSW 2072
Country
Australia
Secondary sponsor category [1] 268968 0
None
Name [1] 268968 0
Address [1] 268968 0
Country [1] 268968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271938 0
Hawkesbury HREC of Northern Sydney Central Coast Health
Ethics committee address [1] 271938 0
Research Business Unit Level 2 Building 51, Royal North Shore Hospital Pacific Highway St Leonards NSW 2065
Ethics committee country [1] 271938 0
Australia
Date submitted for ethics approval [1] 271938 0
Approval date [1] 271938 0
27/09/2010
Ethics approval number [1] 271938 0

Summary
Brief summary
The trial is investigating how, and to what extent an injection of stem cells, obtained from your own fat tissue, reduces pain & inflammation, repairs structural damage, affects mobility, and affects quality of life in knee osteoarthritis.
Trial website
Trial related presentations / publications
No trial publications are currently available.
Public notes

Contacts
Principal investigator
Name 33234 0
Prof Lyn March
Address 33234 0
Department of Rheumatology Royal North Shore Hospital Pacific Highway St Leonards NSW 2065
Country 33234 0
Australia
Phone 33234 0
+61 2 9926 7351
Fax 33234 0
Email 33234 0
lynmar@med.usyd.edu.au
Contact person for public queries
Name 16481 0
Ms Tanya Fedorova
Address 16481 0
Department of Rheumatology
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country 16481 0
Australia
Phone 16481 0
+61 2 9926 6470
Fax 16481 0
Email 16481 0
tanya_f@med.usyd.edu.au
Contact person for scientific queries
Name 7409 0
Prof Professor Lyn March
Address 7409 0
Department of Rheumatology
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Country 7409 0
Australia
Phone 7409 0
+61 2 9926 7351
Fax 7409 0
Email 7409 0
lynmar@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary