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Vision – Mission
The vision of CASC8 is to bring cardiac atrial stem cell (CASC) technology from the current preclinical stage to application in the patient in everyday clinical practice, and to make the technology accessible for a large group of patients, based on a cost-effective production and logistics of the Advanced Therapy Medicinal Products (ATMP). CASC8 wants to rethink the production of autologous stem cell products, lowering total cost.
Problem
Heart failure (HF) is a major global health concern affecting approximately 64.3 million people worldwide. HF is associated with a substantially increased morbidity, mortality, poor quality of life and a significantly higher economic burden on national healthcare systems.
Across the globe, 17 – 45% of patients admitted to a hospital with heart failure, die within 1 year after hospitalisation and the majority dies within 5 years of admission.
In Belgium, the prevalence of HF increases strongly from the age of 75. On average, the Belgian HF mortality is 19%, 6 months after diagnosis and even 26%, 12 months after diagnosis.
Actual therapies continue to improve, but they are still insufficient, targeting physical complaints, but not replacing the lost cardiac tissue. Currently, the main HF treatment options are as follows:
CASC8 is developing a regenerative therapy for Heart Failure (HF), using autologous Cardiac Atrial Appendage Stem Cells or CASCs, reversing the decreased heart function by replacing the lost cardiac tissue.
HF treatment using CASC technology consists of the following steps:
· Diagnosis of HF
· Harvest of CASCs (from the atrium of the heart) is an integral part of conventional cardiac surgical procedure or can be done during a stand-alone, elective (non-urgent), minimal access procedure.
· Expansion: In a GMP clean room, the CASCs are isolated and expanded, reaching a cell number of approximately 500 million cells in 21 days, coinciding with passage 3.
· Transplantation: The autologous CASCs are transplanted during a non-invasive percutaneous TESI (trans endocardial stem cell injection) procedure of maximum 2 hours. CASCs are administered at the border zone between the necrotic and healthy heart tissue, using electro-anatomical/mechanical mapping. The mapping of the human heart takes 30 to 40 minutes, followed by the injection of the CASCs, taking 30 to 60 minutes. Based on the safety and feasibility studies in mini-pigs, no risk for the heart was found.
Value Proposition
CASC8 brings the life of CHF-patients back to normal, using autologous cells derived from atrial appendage. Patients with a reduced global left ventricular ejection fraction will be best served by this therapy, particularly those with dilated ventricles. An average improvement of 15% LVEF will restore cardiac function to (near) normal.
effect of cell transplant on survival
Unique Selling Points
CASC technology is a unique treatment of heart failure:
· CASCs are isolated from autologous cardiac tissue, · CASCs are different from previously reported progenitor populations (c-kit+ /CDCs), · Selection of CASCs is based on the presence of intracellular ALDH, · CASCs differentiate into adult cardiomyocytes,
CASC8 holds following strong points as cell therapy company:
· Growing target population for HF, worldwide · Preclinical phase is completed · Fast track to the market (2028) · Holistic approach on the development of ATMP and the production technology.
