Dedicated to develop
novel stem cell therapies
to treat chronic diseases

Challenge

There is a large unmet clinical need for stem cell treatment of chronic diseases, however stem cell populations including Adipose Derived Regenerative Cells (ADRCs) are heterogenous and our understanding of their in vivo origin and properties is incomplete. Stem cell treatments hold the promise of modifying or even curing diseases, however the current regulatory environment need strong data for approval.

We have discovered that one specific cell type, dubbed ‘Blue Cells’ has remarkable clinical effects in multiple diseases. In phase 1 trials, we have found that a single injection of the patients own ADRCs reversed erectile dysfunction in prostatectomized men. Only the Blue Cells correlated with clinical efficiency.

Mission

Our mission is to translate knowledge from basic science and animal experiments into novel treatments for chronic diseases including erectile dysfunction using specific stem cell types including the so-called Blue Cells that are a subset of ADRCs with angiogenic and regenerative properties.

Goals

Our goal is to introduce Blue Cell treatment for Erectile Dysfunction as the gold standard in hospitals and clinics to make the treatments available to patients worldwide. We shall develop Blue Cell products and methodologies in two steps: first, we will treat the patients with their own Blue Cells to obtain facilitate regulatory approval, and secondly, we shall use knowledge and data from step 1 to develop an allogenic therapy product.

To develop new enzymes and equipment for Blue Cell isolation in order to increase efficiency and to reduce the treatment price by a factor of 2-3

1

To develop a GMP compliant cell culture of the blue cells isolated from the patients own adipose tissue

2

To establish reproducibility, safety, efficacy and adverse effects of autologous Blue Cells for treatment of erectile dysfunction and lymphedema

3

To develop a GMP compliant Blue Cell culture for allogenic treatment

4

"The safety of using the patients
own Blue Cells will increase
acceptance for large scale uptake."

SOREN SHEIKH | CO-FOUNDER

History

5 years ago, Søren P Sheikh (SPS) took on a challenge, could he actually get a new stem/progenitor cell treatment to the patients?

To achive the new goal SPS took a leave of absence and traveled round the world for 3 months to visit multiple laboratories. This resulted in choosing Adipose-Derived Regenerative Cells (ADRCs) as the cells to use for therapy since approved systems for isolation existed and possibly the regulatory bodies would be forthcoming because these cells come from the patient him/her self. The disease Erectile Dysfunction (ED) was chosen because there was very good preclinical data showing ADRCs could correct ED in a rat model, but this had not been tested in humans.

In 2016, the Danish Medicines Agency approved a phase 1 trial using ADRCs to treat ED after operation for prostate cancer at Odense University Hospital in Denmark. These men had no erectile function, and no effect of drugs like Viagra. The results were promising, 64% of the men regained erectile function and ability to perform intercourse (Haahr, EBiomeidicne, 2016, Haahr, Urology, 2019). 

 

Our researchers keept 20% of each ADRC mixture for laboratory analysis, and surprisingly only one cell type, identifyed by flowcytometry dubbed Blue Cells, among the 12-14 different cells in the ADRC mixture, correlated with the regenerative effect on ED. Next, the Blue Cells were isolated and in vitro assays, single cell RNA sequencing and proteomics show strong angiogenic and regenerative potential of these cells.

In parallel, these data were supported by results from a new phase 1 trial for lymphedema in women operated for breast cancer (Toyserkani, Stem Cells Transl. Med. 2018). Again, only the Blue Cells correlated with the clinical improvement of the affected arm.

Blue Cell Therapeutics aim to use the Blue Cells as a platform for autologous and allogenic treatment for several diseases including erectile dysfunction.

Blue Cells

Although the literature provides compelling evidence for the safety and efficacy of ADRCs, the nature of acquired cells is highly heterogeneous and different methods of isolation and preparation yield different and often in…

Backers

The company is a spin-out from University of Southern Denmark and Odense University Hospital. The effort to get ADRC treatments to the patients has been supported by 25 mio. DKK and 5 mio. DKK Grand Solution grants from the Danish Innovation Fund to SPS and the team at Odense University Hospital and University of Southern Denmark. In addition, Blue Cell Therapeutics’ application for the Eurostars program was ranked 17 out of 400 applications in EU, resulting in a 600.000 EUR grant. Novozymes is a partner in both the Innovation Fund and Eurostar projects.