An observational long term follow-up safety and efficacy study of the MAG200 randomised controlled study to evaluate allogeneic adipose-derived mesenchymal stem cells in the treatment of symptomatic osteoarthritis of the knee.
Not Applicable
Completed
- Conditions
- osteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12621000622808
- Lead Sponsor
- Magellan Biologicals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
i) Body mass index BMI must be 'greater than or equal' to 19.0 kg/m2 and 'less than or equal to' 35.0 kg/m2;
ii) A documented diagnosis of osteoarthritis (Grade 2 or Grade 3) of the study knee
iii) Participants enrolled in the interventional MAG200 study (ACTRN12617001095358)
Exclusion Criteria
i) MRI-confirmed displaced meniscal tear, ligament deficiency or generalised Grade 4 chondral loss in the study knee.
ii) History of or suspected infective or inflammatory joint disorders.
iii) Joint surgery within 3 years prior to study start.
iv) Females who are pregnant or planning a pregnancy during the following 12 months.
v) Any contraindication to intra-articular injection.
vi) Any contraindication to an X-ray or MRI of the study knee.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder Analysis as determine by Pain (as assessed by numeric rating scale [NRS]) and Function (as assessed by Knee Injury Osteoarthritis Outcome Score Subscale - Function in Daily living [KOOS ADL]). [ ];Responder Analysis as determine by Pain (as assessed by numeric rating scale [NRS]) and Function (as assessed by Knee Injury Osteoarthritis Outcome Score Subscale - Function in Daily living [KOOS ADL]). [ 12 months post Day 0 (First day of treatment)]
- Secondary Outcome Measures
Name Time Method