Regeneus is an Australian regenerative that has developed an experimental treatment for arthritis called HiQCells. HiQCell is a stem cell treatment made from the patient’s own adipose (fat) tissue, and is subsequently injected into an affected joint or tendon. Regeneus has tested their HiQCell treatment in an independent clinical study that examined the efficacy of injections of HiQCells into the joints of patients with osteoarthritis of the knee. The study examined 40 patients with knee osteoarthritis. Half of these patients received the placebo and half HiQCell in a double-blinded study. When asked about their pain levels six months after the procedure, patients in the placebo and HiQCell group ~45% of patients reported less pain and by 12 months after treatment 55% of patients in both groups reported less pain. Thus both treatments relieved pain to a similar degree. However, when the progression of the disease was examined, a very different result was observed. As osteoarthritis progresses, some of the breakdown products of joint cartilage appear in urine and blood. By collecting urine and blood samples from osteoarthritis patients, the progression of the disease can be readily tracked. Blood and urine testing showed significantly less cartilage breakdown in the HiQCell group and significantly more breakdown in the patients in the placebo group who had advanced cartilage damage. Thus, even though the patients who received placebo had about the same level of pain reduction over the six-month period, it seems that their cartilage breakdown progressed at a faster rate.
Now a follow-up examination of these and other subjects who participated in this initial clinical study has revealed something surprising. According to Regeneus, as of July 21, 2014, from a collection of 386 patients: 1) Pain has continued to decrease two years post-treatment; 2) One year after treatment, 63 of 86 patients reported more than a 30% reduction in pain;
3) Two years after treatment, 14 of 17 patients reported more than a 30 % reduction in pain and 14 patients experienced an average pain reduction of 84% at two years post-treatment; 4) Patients also reported significant improvements from pre-treatment in knee-function, sleep quality and reduced pain medications. Finally, it is clear from these results that HiQCell is a safe therapy and well tolerated by patients, since the frequency and severity of adverse effects of patients who received HiQCell treatments were no different from those received the placebo.
The HiQCell Joint Registry established by Regeneus is the first of its kind in that the patients who participate in this study are subjected to long-term follow-up and undergo stem cell therapy using the patient’s own fat-derived stem cells. The HiQCell study has been approved by a human research ethics committee. These 386 patients included in the Joint Registry will continue to be followed for up to 5 years with analysis updated regularly.
Professor Graham Vesey, CEO of Regeneus, comments: “The registry data is demonstrating that HiQCell has a therapeutic benefit for longer than 2 years. We are now also beginning to see very encouraging data from patients that have had cells frozen for future injections. This combination of the long-term effect from HiQCell and the successful storage of cells for repeat injections in the future, means that HiQCell can be used to treat joint pain for many years. This is particularly important for patients that are too young for joint replacement or are simply looking to delay joint replacement.”