Below are some of the most common questions that we receive. If you have any further queries or would like to learn more about investing, please contact us.

“Mesenchymal stem cell” or MSCs refer to cells isolated from stroma, the connective tissue that surrounds other tissues and organs. These cells can be harvested from bone marrow, placentas, umbilical cords and fat. MSCs are pluripotent – or capable of giving rise to other different cell types – and offer regenerative effects for tissue while moderating the immune system.

It is important to note that not all MSCs are the same. Their characteristics depend on where in the body they come from and how they are isolated and grown. Isopogen has a patented process to treat MSCs, resulting in more clinically efficacious cells.

MSCs offer two primary properties: tissue regeneration and immunomodulatory (immune moderating) effects. StemSmart is made from cultivated MSCs that are treated according to a patented process, offering more efficacious cells with the potential to treat a variety of immune and inflammatory disorders. 

Globally more than 2 million people suffer from Crohn’s Disease – a debilitating auto-immune disorder characterised by chronic, and sometimes life-threatening, gut inflammation. It’s estimated that each year Crohn's Disease costs the global economy more than US$7.5b, with drawbacks to current treatments including serious side-effects and daily administration.
Crohn’s disease is an auto-immune disorder whereby the patient’s immune system attacks itself. By interacting with a patient’s immune system to control the inflammatory response, products created using the StemSmart™ technology can moderate this immune attack, and reset the immune system of Crohn’s sufferers. An 80% clinical response and 53% clinical remission was reported in a Phase II clinical trial to treat life-threatening (refractory) Crohn’s Disease. These patients received just a single, non-invasive treatment.
While clinical trials of products made using StemSmart™ have focused on the treatment of Crohn’s Disease, the potential of MSCs to treat other auto-immune diseases is widely published, suggesting significant potential across a range of auto-immune conditions like Rheumatoid Arthritis.

Many stem cell therapies require matching of patient and treatment tissue creating added costs and delays in treatment. Unlike these autologous stem cell treatments, products made using the StemSmart™ technology are “off-the-shelf” treatments that can be used without the need for tissue matching or the cultivation of a patient’s own cells.

“Mesenchymal stem cell” (MSC) are cells isolated from stroma, the connective tissue that surrounds other tissues and organs. These cells can be harvested from bone marrow, placentas and umbilical cords. Cellular medicines made by Isopogen are made from harvested bone marrow cells.
MSCs have different characteristics depending upon the part of the body they are from, and how they are isolated and grown. These variables create differences between MSC treatments. For more than a decade, Isopogen has created unique intellectual property and GMP-compliant processes aimed at optimising the activity of its cells. After a rigorous donor screening program to ensure batch consistency, stem cells are isolated from donor bone marrow, and are then cultivated and treated according to the patented StemSmart™ technology that results in more active and clinically-efficacious cells. The activity of these products have been proven through positive clinical trials to treat Crohn’s Disease, Kidney Transplant Rejection and Lung Transplant Rejection.

Isopogen has an expanding patent portfolio for the StemSmart™ manufacturing process, which is shown to improve the clinical efficacy of Mesenchymal Stem Cells (MSCs).
Patents are currently held in Australia, the United States, Singapore, South Africa and Israel, with patents pending in Europe, Canada, Japan and Brazil.

During the manufacturing process, Mesenchymal Stem Cells (MSCs) are grown, or expanded. As cells are expanded further, risks of abnormality increase. In the interests of safety, Isopogen caps the expansion of cells, meaning additional donor cells are required to achieve scale.  
 
To increase annual production to 10,000 products approximately 70 donors would be required. These donors may be accessible through national donor registries. 

The StemSmart™ technology is applied to cells isolated from donor bone marrow. These donors undergo rigorous and extensive medical assessment and testing to ensure donor suitability.
To ensure product consistency, comprehensive selection criteria and testing are conducted including growth type, phenotype and cytogenetic analysis. These test protocols are audited under the existing Therapeutic Goods Administration (TGA) licenses and are compliant with Good Manufacturing Practice (GMP).