Preclinical Development

Mesenchymal stem cells (MSCs) are a type of adult somatic stem cells that can be isolated from various sources and expanded in vitro. Genetically enhanced MSCs have been used extensively in treating many non-pulmonary diseases in preclinical animal models. Considerable evidence in the literatures have shown that MSCs may be “immune-privileged”, potentially permitting their use in allo-transplantation (i.e., cells from another individual) without the need for immunosuppressive therapy. The use of allogeneic cells would make it feasible for MSCs to be delivered as an “off-the-shelf” product for the treatment of acute and chronic disorders. Northern Therapeutics Inc. is actively working on developing the next generation of MSC therapy for chronic indications such as pulmonary arterial hypertension, and acute indications such as sepsis and ARDS.

Sepsis

Sepsis is a common and frequently fatal condition characterized by a dysregulated host response to infection and organ dysfunction [1]. This means that the body injures its own tissues and organs in response to an infection. Septic shock is a subset of sepsis identified by persisting hypotension, despite sufficient fluid resuscitation where circulatory and cellular/metabolic abnormalities greatly increase mortality [1].

A devastating and potentially lethal condition, sepsis is one of the leading causes of patient death in the intensive care unit (ICU) of hospitals in the United States [2]. Accounting for as many deaths as acute myocardial infarction, sepsis is likely to increase substantially in incidence as the population ages [3] . Current sepsis management options consist of early goal-directed resuscitation, antibiotic therapy, glycemic control, and recombinant activated protein C for patients with severe sepsis and high risk for death by clinical assessment [4]. Infectious etiologies, such as sepsis and pneumonia, are leading causes of acute respiratory distress syndrome (ARDS) [5]. Sepsis is known to have the highest risk of progression to ARDS [5].