The Osteoarthritis Stem Cell Advanced Research Study
- Conditions
- OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12611001046998
- Lead Sponsor
- Regeneus Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome 1: Change in ICOAP pain scale[at 4, 12 & 24 weeks after intervention];Primary Outcome 2: Percentage of patients achieving OMERACT-OARSI responder criteria.[at 4, 12 & 24 weeks after intervention]
- Secondary Outcome Measures
Name Time Method Secondary Outcome 1: Analgesic use. A daily diary is completed by the patient to record analgesic use.[at 1, 4, 12 and 24 weeks];Secondary Outcome 2: Change in KOOS disability scale[at 12 and 24 weeks];Secondary Outcome 3: Australian Assessment of Quality of Life Index[at 12 and 24 weeks]