Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis.
Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability,
reduced range of motion, and functional limitations. Current treatment limitations have
generated interest in alternative options to restore function and alleviate joint pain, some
with the aim of healing damaged articular cartilage. There has been preliminary support in
the literature for reduced pain and improved functional performance in patients who receive
mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are
limited by complex regulatory issues. This interest in an alternative isolation method lead
to the development of Lipogems. Lipogems is a technique to harvest, process, and inject
minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal
expansion or manipulation. The goal of this study is to evaluate the possible benefits of
reduced joint pain and increased joint functionality in patients with knee osteoarthritis
after the injection of Lipogems. In addition, given the limitations of prior research on the
efficacy of intra-articular corticosteroids, the investigators will also include this as an
additional study group to compare to placebo. There have been case reports published showing
favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems
for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of
patients.
The investigators hypothesize that patients who receive an injection of Lipogems will
experience a decrease in pain of the affected knee and an increase in joint functionality in
comparison to placebo. The investigators also hypothesize that patients who receive an
intra-articular corticosteroid will experience decreased pain or improved functionality in
the affected joint compared to placebo.