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PROducing Stem Cells for improved Treatment of patients

Periodic Reporting for period 1 - PRO-SCT (PROducing Stem Cells for improved Treatment of patients)

Reporting period: 2019-06-01 to 2019-11-30

In the PRO-SCT project Cell2Cure (C2C) has investigated possibilities for a Stem Cell (SC) therapeutic product (C2C-ASC), with focus on treating heart and other diseases.
Pre-clinical and clinical studies have suggested, that SCs can be used in treatment of heart- and inflammatory diseases and transplant rejection. However, lack of good production and distribution processes have made it difficult to commercialize.
C2C has developed a technology to effectively produce, store, distribute and administer SCs from healthy donor fat (adipose) tissue. C2C-ASC have in clinical trials, improved patients heart function and quality of life. Ongoing trials also show promise in several other disease indications.
It is important for society to have access to clinical grade, high quality SCs for patients with no or limited treatment options.
It is the overall objective to provide patients, physicians and health care systems with easy to use “off-the-shelf” highly effective SC products.
The commercial development possibilities for SC therapeutic products in heart and other disease indications has been investigated. C2C has built a structured contact system to increase value of customer relations. The current market intelligence status is established and a list of sub-licensing collaborators (and competitors) is established.
There are several companies working in the SC therapy field, but few products are on the market. Therefore, there will be room for C2C-ASC products. So, the business idea is confirmed.
C2C’s product portfolio has been expanded from 1 dosage type to 4, that today all are in broad clinical indication testing.
The IP portfolio protecting our technology has been analyzed and a freedom to operate analysis has been made.
An updated business plan that cover all aspects from business opportunities, market, pricing, assessment of risk and threats, competition, and future funding is made.
Both the production, storage and quality of C2C-ASC and the clinical data obtained, is far beyond state of the art in our field.
TheC2C-ASC proof of principle will have a significant impact on future investments in research and regenerative medicine and pave the way for new treatment approaches. The socio-economic impact of new medical technologies like C2C-ASC will be significant.
The PRO-SCT project, may also increase the attractiveness of Europe as a location to develop new therapeutic options, and attract new companies and non-EU, meaning more jobs and a more competitive Europe.
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