Off-the-Shelf Stem Cell Therapy Reduces Pain by 58%, Regenerates Cartilage

by Andrii Buvailo, PhD          Biopharma insight

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Topics: Clinical Trials   
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A clinical trial of a novel off-the-shelf stem cell therapy for knee osteoarthritis has shown significant improvements in pain relief and joint function, offering hope for patients suffering from this degenerative condition. The treatment, developed by the Australian biotech company Magellan Stem Cells, demonstrated its potential to halt disease progression with just a single injection.

What is Stem Cell Therapy?

Stem cell therapy for osteoarthritis leverages the regenerative potential of mesenchymal stem cells (MSCs), which are multipotent cells capable of differentiating into various cell types, including cartilage, bone, and fat cells.

There are several approaches to stem cell therapy: autologous, where cells are harvested from the patient’s own body, and allogeneic, where cells are obtained from a donor.

Autologous stem cell therapy involves extracting cells from sources such as bone marrow or adipose tissue, processing them, and then reinjecting them into the affected area. While this method minimizes immune rejection, it is labor-intensive and costly.

Allogeneic stem cell therapy, on the other hand, uses stem cells from a donor, making it an off-the-shelf product that is more convenient and scalable.

Stem cell therapy has achieved several notable successes, particularly in the treatment of blood disorders and regenerative medicine. One prominent example is the use of hematopoietic stem cell transplantation (HSCT) to treat acute myeloid leukemia (AML). At MD Anderson Cancer Center, a patient achieved complete remission from AML after undergoing a stem cell transplant following chemotherapy and a clinical trial with a targeted drug.

Additionally, research has demonstrated significant improvements in the outcomes of elderly patients with AML who received allogeneic HSCT. Studies have shown that leukemia-free and overall survival rates have improved significantly since 2000, highlighting the advancements in stem cell transplantation techniques and patient management.

In the field of regenerative medicine, the Abu Dhabi Stem Cells Centre has successfully performed over 100 bone marrow transplants, underscoring the widespread applicability and success of stem cell therapies in various conditions.

Moreover, a study published in Blood reported that women who underwent allogeneic HSCT could achieve successful and safe pregnancies. This study, conducted in Germany, assessed pregnancy-related outcomes and found that despite the intensive conditioning regimens required for transplantation, a significant number of women were able to conceive and carry pregnancies to term.

 

The New Milestone for Regenerative Medicine

In 2020, osteoarthritis affected 7.6% of the global population, a figure that has surged by 132.2% since 1990. Predictions indicate a further increase in cases by 2050, particularly for knee, hand, and hip osteoarthritis. Current treatments focus primarily on pain management using non-steroidal anti-inflammatory drugs (NSAIDs), exercise, and joint replacement surgery. However, these methods do not delay the disease’s progression and can carry significant long-term risks, such as stomach ulcers and cardiovascular issues.

Prof. Julien Freitag, Magellan Stem Cells’ Executive Director and Chief Medical Officer.

 

Magellan Stem Cells' new therapy, MAG200, utilizes mesenchymal stem cells derived from adipose tissue. This approach avoids the labor-intensive process of harvesting a patient’s own cells and does not trigger an immune response due to the use of allogeneic cells. In a first-in-human Phase I/II trial, 40 participants with moderate knee osteoarthritis received either the MAG200 injection or a placebo. The participants, who had an average pain score of at least five on a scale of zero to ten, were assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS).

The trial’s primary efficacy objectives were to achieve clinically meaningful reductions in pain and improvements in function at 12 months. The results were promising: 75% of participants receiving MAG200 showed statistically significant improvements in pain and joint function, with a sustained 58% pain reduction at 12 months. MRI scans confirmed improvements in cartilage volume and quality among treated participants.

Associate Professor Julien Freitag, Magellan’s Executive Director and Chief Medical Officer, highlighted the significance of these findings. “Magellan’s stem cell therapy – with observed pain and functional improvement and indication of disease modification – promises to delay or prevent the need for joint replacement surgery. These results represent a pivotal moment for the management of osteoarthritis and may change the way we practice medicine in the future.”

Further research is anticipated to reinforce these findings and broaden the availability of this treatment to osteoarthritis sufferers globally. The success of MAG200 in clinical trials positions it as a potentially transformative therapy in the ongoing battle against osteoarthritis, potentially improving the quality of life for millions worldwide.

Topics: Clinical Trials   

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