Project Overview

Millions of patients with diabetes mellitus in the EU are using prescription drugs to control their blood glucose levels. Poor control of blood glucose levels leads to a number of diabetic complications, including: nephropathy, retinopathy, cardiomyopathy, neuropathy, impaired bone repair and wound ulceration. At present, there are few therapeutic options available to control initiation and progression of diabetic complications and they continue to present challenging disease management issues for clinicians.  The REDDSTAR Project will comprehensively examine if Stromal Stem Cells can safely control glycaemia and alleviate damage caused by six diabetic complications.

Stromal Stem Cells (SSC)

As noted above the REDDSTAR Project will involve the isolation and testing of Stromal Stem Cells (SSC).

Stromal Stem Cells

Stromal Stem Cells (SSC) are a mixed population of plastic-adherent (PA) cells isolated from adult bone marrow [1]. PA-SSC secrete potent proteins that impact the immune responses and stimulate the growth of new blood vessels [2].  Preclinical studies show that a single intravenous administration of PA-SSC can control rodent hyperglycaemia [3].

REDDSTAR partners have identified an antibody [4] (ORB1) that prospectively isolates  ORB1+ SSC from human, rat, mouse and rabbit marrow, enabling testing of pure ORB1+ and ORB1- SSC and mixed PA-SSC from each species for the first time.

REDDSTAR partners have collectively developed in vivo models of six important diabetic complications.  The project will assess if ORB1+, ORB1- and PA-SSC exert differing levels of control of blood glucose and tissue repair in each model of diabetes. In addition, the project will determine how ORB1+ and ORB1- SSC simultaneously repair tissue damage and maintain blood glucose control, an effect not observed with any current therapy. The model with the most promising results will be selected for progression to a Phase Ib clinical study [5].

Phases of the Project

REDDSTAR will involve a number of phases, spread over 3 years.  The first 18 months of the project will involve investigating the safety and efficiency of SSC in resolving the 6 complications arising from diabetes.  The impact of SSC upon blood glucose levels will also be tested.  This phase of the project will also see the development of appropriate procedures for the isolation and production of ORB1+ and ORB1- SSC from human bone marrow using the Nanosorter ®[6].

The second 18 months of the project will involve examining how SSC improves diabetic complications.  REDDSTAR partners will also submit a clinical trial application to the Danish Medicines Agency to undertake clinical trials on diabetic patients with the complication(s) that yield the best results in phase 1 of the project.

 

Innovation and Societal Value of REDDSTAR

 


[1] These cells are typically characterised by rapid adherence to tissue culture plastic (“plastic adherent” or PA).The definition of what constitutes SSC (and its characteristics) was outlined by the International Society for Cellular Therapy (ISCT) in 2006.

[2]  Immunomodulatory and angiogenic proteins.

[3] High blood glucose

[4]  A protein produced by the body’s immune system in response to a harmful substance or antigen e.g. bacteria, virus, fungus, parasite.

[5]  A Phase 1 study involves testing of a drug or treatment on a small group for the first time to evaluate safety, appropriate dosage range and side effects.  Phase 1b studies are generally conducted with patients the disease or condition for which the drug or treatment is intended.

[6]Nanosorter is a registered trademark in the US and references to Nanosorter® throughout this website should be construed accordingly

 

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