Clinical Trials
Regeneus is committed to conducting research to international standards in order to further understand and document the benefits of its regenerative medicine technologies.
As part of this commitment, Regeneus has sought and been granted approval to conduct a Phase II clinical trial of HiQCell therapy for knee osteoarthritis. The study is being conducted by independent researchers at the University of Sydney. This trial will provide important information on post-treatment measures of pain, inflammation and structural change in arthritic joints. This information will assist in the development of better treatment options for the care of people with osteoarthritis.
*Please note: Participant recruitment for the Phase II Clinical Trial is now closed*
Trial Name: A single-centre, randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of autologous non-expanded adipose derived stem cells in the treatment of knee osteoarthritis.
Status:
Active
Registration Body:
Australian New Zealand Clinical Trial Registry
Trial Site:
Royal North Shore Hospital (Sydney)
Purpose of Trial: This is the first double-blind, randomised controlled trial investigating autologous adipose-derived Mesenchymal Stem Cells in a single treatment for a knee osteoarthritis.
The trial will evaluate the effects of the HiQCell procedure on reduction of pain and changes in other measures of Quality of Life (QOL) in relation to knee osteoarthritis. Medication use before and after the procedure is also documented to determine if there is any reduction in medication use following the procedure. MRI, gait and blood analysis will also be performed before and after the procedure. The trial is a randomised, placebo-controlled, double-blinded study. The use of a placebo control means that half of the patients will receive a "dummy" injection instead of the HiQCell cell mixture. In addition, neither patients nor doctors will know which injection has been given to each patient. This will be revealed only at the end of the study to enable unbiased collection of the data. Recruitment is being conducted by the study investigators and will continue until the end of 2011. Once data collection is complete, the data will be analysed and results published.
Outcome measures include:
- Pain: ICOAP pain scale, OMERACT-OARSI responder criteria, and use of pain medication
- Inflammation: Cytokine analysis (blood and joint fluid)
- Structural Damage: X-Ray and MRI analysis
- Mobility: Gait analysis
- Quality of life: AQoL index