None listed
Conditions
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]).
Interventions
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.
Sponsors
Kade Paterson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed