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Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE)

Periodic Reporting for period 3 - SCIENCE (Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE))

Reporting period: 2018-01-01 to 2019-06-30

Ischemic heart disease (IHD) caused by coronary artery disease is the most common cause of death with more than 17 million deaths worldwide each year and a major cause of hospital admissions in industrialized countries. It is an increasing economic health problem due to increasing morbidity in an ageing population. Classical therapies have reduced mortality of IHD significantly but left an increasing number of patients with chronic IHD and/or heart failure without further treatment options.

There is an unmet need for novel, effective treatments for chronic IHD and heart failure to improve patient’s survival and quality of life and reduce health care costs. Stem cell therapy is emerging as a viable therapeutic option in this patient group as well as in several debilitating diseases for which no cure is currently available.

The overall aim of the SCIENCE project is
• to conduct a multi-center double-blind placebo-controlled trial with stem cells from healthy donors to improve myocardial function in patients with ischemic heart disease and heart failure.
• establishing a manufacture facility for centralized production of the stem cell product in Copenhagen, Denmark.
• establishing financial health care data to demonstrate the impact of implementing stem cell treatment
• evaluating advanced existing and new imaging techniques of the function of the heart in order to establish future more precisely guided delivery of stem cells
Within the first 54 months grant period the consortium has established the centralized production of stem cells for the clinical trial in Copenhagen, Denmark.

The approval of the clinical project has been a little delayed due to new regulation for some of the component used in the stem cell production, which was released late 2015 to be implemented 2017. The new regulation was released after our submission of the project to the competent authorities for an approval. We therefore had to establish a completely new production of stem cell for the clinical trial based on the upcoming new regulation and initiate a new approval process. This new production plan is now approved by the competent authorities in the involved countries and the new production of the stem cell product has been initiated.

The national Competent Authority approval process was delayed in some countries. The last approval was in Poland August 2017.

There has been developed guiding protocols describing all practical steps in the clinical trial from including patients, testing the capacity of the patients and their heart function, handling of and treatment with the stem cells etc. to optimize the patient treatment and minimize the risk in the study.

The plan and protocols for the imaging investigation of the patient’s heart function with Echocardiography, Computer Tomography and Magnetic Resonance Imaging are all developed and tested by the participating clinical partners.

The trial was put on hold by the Sponsor September - November 2017 due to problems with the injection catheters.

The first patient was treated January 2017. A total of 126 patients have now been treated without any complications or adverse events caused by the stem cell product. The remaining 12 patient will be included within the next months.

We have established an organization for initiating and monitoring of the six involved clinical departments in Slovenia, Germany, Austria, Poland, The Netherlands and Denmark. There is an intensive ongoing monitoring plan to secure a high quality of data entry into the e-CRF to ensure readiness for the statistical analyses, when the last patient follow-up is in place.

We have developed a plan for the evaluation and impact of the stem cell therapy on health economy.

The analysis of the imaging data is ongoing and following the plan to be ready when the last patient follow-up is in place.