ROBOTICS HEALTH


2


1


a better understanding of how the immune system interacts with cellular therapeutics with particular focus on (a) overcoming the allogeneic immune response, (b) developing new strategies to improve


the immune immune


suppressive effects in organ transplant and cardiovascular and orthopaedic diseases, (c) measuring the


therapeutic cells, and (d) discovering novel molecular


mechanisms information to understanding


potency of underlying


mesenchymal stromal cell modulation of immune cells. This programme has been highly successful and has contributed important


immunological aspects of cellular therapies.


OSTEOARTHRITIS Osteoarthritis (OA) is a complex condition with damage to articular cartilage in joints as a predominant feature. The onset of OA may be a slow progression and remain clinically silent


for many years and it is


understood that trauma to the joint, such as meniscal or ligament


damage, are


predisposing factors. We have shown in a number of preclinical


studies that delivery of mesenchymal stromal cells to the injured joint effectively slows down the development of OA. As a result of these studies, these cells remain at


the


forefront of current efforts in cellular therapy for OA. The ADIPOA-2 phase 2b clinical trial is now underway at REMEDI and at other centres in Europe testing autologous cell treatments for knee OA.


DIABETIC COMPLICATIONS A particular area of


focus at REMEDI, under the leadership of Professor Timothy


O’Brien, is the development of treatments for serious complications associated with diabetes. These include non-healing ulcers, critical limb ischaemia (CLI) and diabetic nephropathy. Important new preclinical data has been generated showing the potential of cellular


interventions the in


these conditions. The CLI, REDDSTAR and NEPHSTROM phase one trials are underway to test in patients.


interventions


ADVANCED CELL MANUFACTURING The Centre for Cell Manufacturing Ireland (CCMI) was established as part of the REMEDI translational mission to manufacture


advanced national regulator, the Health


product in a format ready for delivery to the patient. In partnership with IPT Fraunhofer in Aachen, Germany, AUTOSTEM has made


great implementing this platform.


CLINICAL TRIALS The


integrated academic, translational, 6 therapeutic


medicinal products (ATMP) to supply phase one and phase two needs. CCMI is approved by the


Products Regulatory Agency (HPRA) as an authorised manufacturer of cellular products and has fully certified GMP manufacturing suites. An important aspect


of REMEDI’s


manufacturing strategy is the recognition that automated and scaleable production capacity is essential for the growth of the industry. For that reason we have established the AUTOSTEM project. Led by Dr Mary Murphy, this is a robotic cell production factory that will minimise manual operations while producing large batches of cell product in a closed and sterile environment. The process involves extraction of adult


stem cells from tissues such as bone marrow or fat followed by efficient purification and culture


expansion 34 18 in large-capacity bioreactors and finally packaging the INNOVATION IRELAN REVIEW


clinical trial and manufacturing capability at REMEDI makes it an attractive partner for industry, bringing the opportunity for commercialisation of the research effort. REMEDI has the advantage of a close and highly effective relationship with its clinical trial partner, the HRB Clinical Research Facility Galway (CRFG). This is a joint venture between Galway


University Hospitals and NUI Galway and provides infrastructure, space, facilities and expertise bioscience


needed to research, optimally support


aimed at understanding a range of diseases and speedily translating the


focusing on studies knowledge


obtained through this research into approved and reimbursed advances in patient care. CRFG is currently managing the


NEPHSTROM, ADIPOA-2, CLI AND REDDSTAR trials and has become a centre


of excellence in testing cellular


therapies in early patient studies. The future of regenerative medicine is bright and recent


successes have added


momentum to the field. It seems that new therapeutic options are within our grasp and scientists, clinicians and industry leaders see


patients with severe and previously intractable conditions. nuigalway.ie/remedi


realistic opportunities for treating


strides in designing and


1 Professor Frank Barry, Scientific Director of REMEDI; 2 Professor Timothy O’Brien, Director of REMEDI, Head of Medicine at NUI Galway


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60