CellMade Laboratories

CellMade is dedicated to inflammation biology. Inflammation is a localized response to injury or infection characterized by the sequential release of inflammatory mediators and the recruitment of circulating leukocytes.  Recruited leukocytes become activated at the site of inflammation and release further pro- and anti-inflammatory mediators. Sites of acute inflammation are characterized by the rapid recruitment of neutrophils. Sites of chronic inflammation are characterized by the continuing recruitment of monocytes that differentiate into macrophages. Chronic inflammation can cause diseases including but not limited to Type II Diabetes (T2DM), Cardiovascular Diseases (CVD) and Chronic Obstructive Pulmonary Disease (COPD). Typically, patients-at-risk are also suffering from chronic overweight or Obesity. Non-Alcoholic Fatty Liver Disease (NAFLD) is a common factor in Overweight/Obese patients developing T2DM and/or CVD and/or COPD. NAFLD is generally considered as the hepatic outcome of the Metabolic Syndrome.

The ever-increasing prevalence of Obesity affects millions of people worldwide. The Metabolic Syndrome and its hepatic manifestation, NAFLD-NASH is a key pathological condition triggered by the noxious biochemical pathways of Obesity.  Despite the high unmet medical needs, there are currently no approved drugs for treating NAFLD-NASH. The current main recommendation is lifestyle modification, which is only partially effective.

The scientific evidence on the looming pandemic of Obesity is now overwhelming. It is thought that the spreading of the disease is mediated via circulating inflammatory messengers. As in any degenerative disease, early diagnosis is the key to avoid harmful, and even deadly, effects.

There is high demand for a non-invasive, high-accuracy diagnostic and prognostic approach. CellMade identified and validated a set of blood lipids that allow for discrimination between the various stages of NAFLD-NASH enabling to predict patient's risk profile and reactivity to treatment schedules.

The successful validation of the biomarker signatures represents a cornerstone advancement to address the societal challenges related to the Obesity pandemic and the development of associated comorbidities such as T2DM, CVD and COPD. Early diagnosis will overcome the costs issues affecting the current clinical scenario, as the disease development is still reversible and could be addressed therapeutically.

CellMade’s lead product, CLM-101, co-developed along with diagnostic and prognostic biomarker signatures (CLM-BM-001 for T2DM; CLM-BM-002 for CVD and CLM-BM-003 for COPD), is evaluated for indications in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD, NASH >5%), potentially overcoming later development of T2DM and/or CVD and/or COPD.