Regenerative medicine company, Regeneus (ASX: RGS) announced further results from its ethics approved joint registry used to track the safety and effectiveness of its innovative cell therapy, HiQCell®, in the treatment of osteoarthritis.
The interim report of 305 patients as at 23 January 2014 has found that:
- Patients reported continued improvements at 12 months post-treatment;
- The small number of patients (n=7) within the Registry that had reached 24 months post-treatment also show continued improvements;
- Patients reported significant improvements in pain, function, sleep quality and reduced usage of pain medications;
- 73% of patients treated experienced a significant (greater than 30%) reduction in pain with an average reduction of 79% across all age groups and osteoarthritis grades;
- HiQCell is a safe therapy and well tolerated by patients.
The HiQCell Joint Registry is the first of its kind in the long-term follow-up of patients undergoing stem cell therapy using the patient’s own fat-derived stem cells. Patients in the Registry will continue to be followed for up to 5 years with analyses updated regularly.
Within the registry a patient is classified as a responder if they report a greater than 30% reduction in pain. At 12 months post treatment 56 of 77 patients were responders and at 24 months post treatment 6 of 7 patients were responders.
Professor Graham Vesey, CEO of Regeneus, comments, “the Joint Registry is an important part of the company’s commitment to quality. Recording patient outcomes over the long term is an example of our responsible approach towards furthering the medical community’s understanding of this new therapeutic field. It is exciting that we have registry data available for 12 months and beyond post-treatment for patients. We anticipate that it will also help us to build a case for permitting medical reimbursement to patients.”
The Joint Registry is a voluntary observational registry and all patients treated with HiQCell are eligible for inclusion. Patients are tracked from a pre-treatment baseline, at two weeks, at six months and then annually. Three hundred and five patients had consented to be included in the registry as of 23 January 2014, representing 77% of all patients treated.
The Joint Registry has been developed by Regeneus and Professor Jegan Krishnan, chair of Orthopaedic Surgery at the Flinders Medical Centre, Flinders University, Adelaide.
Timing of the report coincides with the milestone of treating the 1,000th joint with HiQCell, comprising knees, hips, ankles, wrists, shoulders and digits across a cohort of over 450 patients.
Dr Donald Kuah, a leading Treating Medical Practitioner of HiQCell and specialist sports and exercise physician was also very interested in the results. He remarked, “this Registry is extremely valuable as it allows me to track specific outcomes of my own patients as well as being able to observe the treatment effect across all other patients enrolled in the registry.”