Science and Technology
The issue
Osteoarthritis is the focus of Magellan’s research and development. Osteoarthritis is the number one national health priority for many developed nations including Australia as it presents an immense economic burden.
There are currently 100 million people with osteoarthritis in Europe, UK, USA, Canada, Japan and Australia with over 500 million globally. About 20% of these people are over 45 years old, and 80% over 65 years old. With an ageing population as well as other health factors in the rise, these numbers will continue to rise rapidly.
Governments across the world globe are making osteoarthritis a National Health Priority as the consequences to economies, health services and work productivity are significant.
In Australia alone, at least 2.2 million people between 25-64 years old are affected with arthritis at a cost to our economy of more than $23.9 billion AUD every year in direct and indirect costs. This number is projected to increase 58% by the year 2032.
In response to this growing medical condition, the osteoarthritis therapeutics market size was greater than $7.3 billion USD per annum in 2021 and predicted to grow to $11 billion USD per annum by 2025.
Scientific team
Dr Nirali Shah
Laboratory Senior Scientist, Ph.D.
Nirali earned her Ph.D. from Swinburne University in 2014, in umbilical cord-derived MSCs for various clinical applications, she has a passion for developing and utilising mesenchymal stem cell-based models for the treatment of arthritic conditions and identifying novel therapeutics. With more than ten years of comprehensive expertise encompassing various aspects of stem cell culture, such as method development and improvement, cell characterization, and utilization of immunological and molecular analytical characterization methods, her profound fascination lies in cutting-edge cell therapy-related technologies such as 3D culture and help develop the technology that facilitates the advancement of treatments for osteoarthritic ailments. Nirali has undergone GMP training and is developing methods and process validation for stem cell therapy.
Sara Shaba
Laboratory Senior Scientist
Bachelor of Biological Sciences (Microbiology, Genetics)
Sara has in-depth knowledge and technical expertise in cutting-edge technology in cell and gene therapies, regenerative medicine, and cellular immunotherapy, with an emphasis on different CAR-T cell manufacturing. Sara previously worked at Cell Therapies Pty Ltd. (Peter MacCallum Cancer Centre) Cell Therapy Scientist (Cell & Gene Therapy Manufacturing) and brings a wealth of knowledge and experience in working in a GMP facility, quality management system, and regulatory requirements in the cell therapy space.
Teena George
Laboratory Senior Scientist
Masters in Laboratory Technology
Teena has extensive experience in all aspects of stem cell culturing techniques. Specifically in the processing and collection of stem cells from Lipoaspirate tissues, analysis, preparation, and culturing. Her experience extends to bioassay and a range of analytical methods including ELISA, PCR, and protein purification. Teena has gained significant experience in the maintenance of clinically derived stem cell culture, harvest and cryopreservation of stem cells, and routine assessment documentation and maintenance of quality control procedures. She is highly experienced in cell counting processes, cryopreservation, and preparing clinical stem cell dosages. Teena has undergone a GMP uplift training program and is involved in method validation and documentation.
David Petrie
Quality Manager
David has a wealth of experience in the area of GMP Quality Management having previously worked as a Senior Quality Manager at Pfizer and Quality Director of PCI Pharma Services. David’s expertise in Quality Management, Quality Assurance and Regulatory Affairs is invaluable with Magellan’s development of a Contract Development and Manufacturing Organisation (CDMO). David has practical experience in aseptic manufacturing and managed facility GMP inspections with both TGA and international regulatory authorities.
Magellan’s Stem Cell Research
Medical treatment available today focuses on managing pain and symptoms, rather than treating the disease itself. These treatments have limitations, with significant side effects and only some improvement in pain using analgesics, cortisone and hyaluronic acid.
We have entered the era of regenerative medicine and Magellan is in a prime position to take a leading role.
Magellan’s stem cell research is regenerative medicine, harnessing the body’s natural restorative abilities to rebuild normal function.
Magellan Stem Cells partners with like minded organisations and clinicians. In doing so it has provided the stem cell culturing and scientific expertise for the following innovative research and published clinical trials.
Mesenchymal stem cell therapy in Osteoarthritis and regenerative medicine
Product Development Pathway
Magellan Stem Cells is a world leader in the supply of Mesenchymal Stem Cells (MSC’s) to clinicians to treat osteoarthritis. We are aiming to be first to market with a global product for the regenerative treatment of osteoarthritis .
We will begin Phase III which is the Pivotal Clinical and Efficacy study first quarter 2025. This phase includes the final stages of further developing and commercialising MAG200 and an opportune time for investors to join us in going to market. This phase will also include:
- 13 year R&D and clinical trial journey
- Successful P1/2 Allogeneic Trial reviewed by TGA
- Allogeneic Trial synopsis reviewed and accepted by TGA
The TGA have confirmed the study is well designed and upon a successful outcome, will be sufficient for ARTG registration in 2027
