Medistem (MDSM.OB) is a US public company founded in October 2005. It's mission is to discover, develop and commercialize technologies related to adult stem cell extraction and manipulation for use in treating inflammatory and degenerative diseases. The company has a portfolio of products in various stages of development covered by 15 families of patent applications.

The company has developed a novel type of stem cell, the Endometrial Regenerative Cell (ERC) that appears to have the major attributes desirable in an ideal cellular therapy: a) They are derived from non-controversial sources; b) The activity of the cells is not substantially neutralized by the immune system, allowing for use of cells from one standardized source (e.g. universal donor); c) The cells can be administered intravenously since they home to injured or degenerated tissue.

Medistem scientists demonstrated that ERC's are capable of transforming into major tissues of the body including heart, lung, liver, brain, and blood vessels. It was published that ERC's also produce large amounts of therapeutic factors, in some situations at higher levels than other types of stem cells. Medistem collaborators have demonstrated that ERC's are potent inducers of new blood vessel formation in animals lacking proper circulation. To date studies have demonstrated that ERC's do not cause adverse effects when administered at therapeutically-relevant doses to animals.

Medistem plans to enter clinic trials using ERC's for a condition that will demonstrate proof of concept and safety in a rapid and cost effective way.

Approximately 160,000 amputations occur each year due to critical limb ischemia, an advanced form of atherosclerosis. Various types of stem cell therapies have been demonstrated to exert positive effects on this condition through stimulating production of new blood vessels. Unfortunately, the majority of such therapies are impractical or costly. For example, the administration of a patient's own bone marrow stem cells into the ischemia muscle has been reported to improve pain free walking distance and reduce need for amputation. However bone marrow extraction and processing is a fairly involved procedure that is not currently feasible on a wide-spread basis.

The threshold for clinical success using stem cells in CLI is theoretically lower than for other indications since the stem cells are not required to completely differentiate and generate a new organ. For a therapeutic effect the stem cells need only to stimulate the production of new blood vessels, a process called "angiogenesis". In patients with CLI the new blood vessels start providing oxygen and nutrients to the previously ischemic tissue, resulting in healing of ulcers and restoration of leg function.

Bone marrow transplantation is the only successful stem cell therapy that has saved hundreds of thousands of lives. Arguably its success is attributed to the fact that the bone marrow stem cells were required to do what they were naturally meant to do: make blood. ERC's have a specialized function in the endometrium: to make new blood vessels. With every menstrual cycle the endometrium builds up and then sloughs off. This rapid accumulation of highly vascularized tissue, we believe, is associated with the natural ability of the ERC to generate new blood vessels. Medistem's first clinical use of the ERC in the USA is aimed at using this natural ability of ERC's to make new blood vessels in patients with CLI.

Medistem's CLI product is ERC-142, a standardized, "universal donor" cell preparation that is delivered frozen to the doctor's office, and when ready for use is injected into the ischemic muscle of patients with CLI. The planned clinical trials of ERC-142 will assess the ability of this new stem cell population to improve circulation of patients with CLI who have no option but amputation.

Therapeutic angiogenesis is considered a "Holy Grail" of biologics. While the ERC-142 program will spearhead clinical development, Medistem plans to concurrently develop other ERC-based products for therapeutic angiogenesis in other conditions. Ischemic heart conditions are believed to affect approximately 1 out of 100 people, being considered a $25 billion/year market in the US alone. Stimulation of angiogenesis by other stem cells has been demonstrated to improve animal models of stroke, liver failure, and wound healing.

The company has taken an aggressive intellectual property position in various areas related and non-related to the ERC population. In its current 15 families of patent applications, Medistem covers novel uses of stem cells, methods of stem cell expansion, methods of cancer treatment and novel approaches to conditions such as autism and neurodegenerative diseases. All Medistem activities are focused on adult, non-controversial stem cells.