None listed
Conditions
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.
Interventions
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).
Sponsors
Regeneus Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed