New research by Australian biotechnology company Magellan Stem Cells has demonstrated potential for significant therapeutic benefits of an off-the-shelf donor stem cell therapy for Osteoarthritis.
The Phase I/II clinical trial assessed the safety and efficacy of MAG200, Magellan Stem Cells' off-the-shelf allogeneic (donor) stem cell therapy for osteoarthritis of the knee.
"Our research indicates that Magellan's off-the-shelf donor stem cell treatment is safe and effective in improving joint function, reducing pain levels and may have the potential to halt the progression of osteoarthritis," lead researcher Associate Professor Julien Freitag said.
Associate Professor Freitag said the trial provides the evidence-base to justify further research.
Demonstrated benefits of Magellan's MAG200 product include:
- Sustained pain improvement of 58 per cent at 12 months of follow-up
- Quality of life scores more than doubled for patients who received stem cell treatment
"The trial also indicated that Magellan's cell therapy may delay or prevent the progression of osteoarthritis, with observed improvement in cartilage volume in patients receiving stem cell treatment, while the placebo group showed either no change or their osteoarthritis progressed," Associate Professor Freitag said.
Long-term clinical follow-up of the single-centre, double-blind, ascending dose, randomised controlled trial has shown that improvements from a single injection of donor stem cells were maintained beyond four years.
The research findings are published in Osteoarthritis and Cartilage Open the open-access journal of Osteoarthritis Research Society International (OARSI), which publishes the evidence-based, international consensus guidelines on osteoarthritis management.
OARSI is the premier international organisation for scientists and health care professionals focused on the prevention and treatment of osteoarthritis.
Associate Professor Freitag said osteoarthritis is a leading cause of disability globally and represents an unmet clinical need as current therapies offer limited pain relief and may also be associated with significant side effects.
No current therapies delay the progression of osteoarthritis, with an increasing number of patients undergoing total knee replacement (TKR) surgery. More than 65,000 TKRs are performed annually in Australia. The economic cost of osteoarthritis in Australia is more than $25 billion a year, Associate Professor Freitag said.
"More than 30 per cent of total knee replacements in Australia are performed on patients under the age of 65. Magellan's stem cell therapy – with observed pain and functional improvement and indication of disease modification – promises to delay or prevent the later need for joint replacement surgery," he said
"I believe our research results represent a pivotal moment for the management of osteoarthritis and may change the way we practice medicine in the future," Associate Professor Freitag said.
"Cell therapies, including Magellan's donor stem cell treatment, is a promising and rapidly advancing field with a potential to transform medical management of conditions which currently have limited treatment options"
Associate Professor Julien Freitag said the new treatment offers hope to millions of Australians and hundreds of millions of osteoarthritis sufferers around the world.
"One in five Australians over 45 suffer with osteoarthritis and the only treatment options available to most are pain relief drugs, prescribed exercise, and joint replacement surgery," Associate Professor Freitag said.
"But appropriately developed and regulated stem cell treatments have the potential to change all that, providing a more effective, less painful, longer lasting and affordable option.
"Magellan's clinical development of its donor cell therapy – MAG200 – provides Australians suffering from osteoarthritis with early access to an innovative therapy which may later have significant impact on the global healthcare and community burden of osteoarthritis."
"If the results of this PI/II trial are replicated by further research, Magellan's stem cell therapy has the potential to revolutionise the treatment of osteoarthritis, leading to improved quality of life for millions of patients who suffer from this debilitating condition."
"Magellan's off-the-shelf cell therapy promises to have considerable community impact with significant reduction in the socioeconomic burden of osteoarthritis."
"The purpose of our Phase I/II trial was to confirm the safety of Magellan's donor stem cell therapy and provide evidence of efficacy to direct further late-stage research. The observed results with statistically significant and reproducible symptomatic improvements seen in patients provides Magellan with confidence to progress to late-stage clinical development."
Magellan Head Scientific Officer, Dr Kiran Shah said: "We are excited to have been able to develop a world-leading cell therapy within Australia."
Magellan Board Director and CFO, Mr. Ross Williams said: "Magellan's research and development path is an example of Australia's investment in advanced manufacturing technologies and reduces Australia's reliance on offshore manufacturing and therapeutic development."
LINK: The Phase I/II study is published in Osteoarthritis and Cartilage Open.
Osteoarthritis: fast facts
- Osteoarthritis is the fourth leading cause of disability worldwide
- Osteoarthritis is recognised as a National Health Priority by the Australian Federal Government
- Symptomatic osteoarthritis affects 1 in 5 Australians over the age of 45
- Surgical total joint replacement remains the accepted treatment for knee OA that does not respond to conservative therapies. With joint replacement, up to 20%-30% of patients experience persistent pain and loss of function at 12 months.
- Without new therapies, the number of knee replacements performed each year in Australia is expected to grow significantly. Between 1994 and 2013 the number of annual total knee replacements grew from 12,030 to 46,848 (a 289% increase).
- Over 65,000 total knee replacements were performed in Australia in 2018-2019.
- Based on expected population growth and the ageing population, total knee replacements are expected to conservatively expand to more than 105,000 by 2046.
- More than 2.2 million people in Australia suffer with osteoarthritis.
- Current healthcare costs associated with osteoarthritis are estimated at $A3.5 billion annually. The associated burden of disease (years of healthy life lost due to disability) results in a total cost to the economy of more than $A25 billion annually (Arthritis and Osteoporosis Victoria 2013).
- In Australia up to one-in-three total knee replacements are undertaken on people aged under 65.
Key Facts:
Phase I/II trial of Magellan Stem Cells MAG200 demonstrates that off-the-shelf donor stem cell treatment is safe and effective.
Findings include:
Improvement in joint function
Reduced pain
Potential to halt progress of osteoarthritis
Results are published online now and in the September edition of Osteoarthritis and Cartilage Open
Link: https://www.oarsiopenjournal.com/article/S2665-9131(24)00067-0/fulltext
About us:
About Magellan Stem Cells: Magellan Stem Cells is a private Australian company with expertise in research, development and manufacturing of stem cells for the treatment of osteoarthritis.
Magellan leads globally in scientific, clinical and commercial expertise for both autologous stem cell treatments which use the patient's own cells, and allogeneic treatments which use selected donor cells. We have more than 10 years of stem cell commercial manufacturing expertise and have cultured more than 400 billion stem cells during this time.
