Human heart repair – NovaThera and scientists in Imperial College (London) and The Texas Heart Institute (US) launch programme to scale up supply of human heart cells for experimental trials

Cambridge UK December 12

Heart disease is a major killer and cause of chronic illness in the western world. A staggering 2.7 million people are estimated to be living with coronary heart disease in the UK – a number rising year on year. Almost one in eight people - or 12% - have been diagnosed with a disease of the heart or circulatory system. This phenomenon results in substantial levels of disability to the patient and significant long term healthcare costs to the NHS and US healthcare systems.

A big factor in the progression of heart failure is the loss of cardiomyocytes (heart muscle cells) following heart attacks. Heart muscle has a limited ability to regenerate and so can not repair itself. Injured cells are replaced by fibrous scar tissue, leading to reduced heart function and disability. In serious cases, heart transplant is the only effective treatment. But there are not enough hearts available for transplantation.

Many believe that considerable advances in treating heart disease could come from using stem cells to repair and regenerate damaged tissues. International efforts towards heart repair are currently happening using bone marrow. However, this involves harvesting cells from a patient who is already badly ill and means each patient has to have the procedure. Embryonic stem cells can be made to turn into heart muscle cells and so can offer huge advantages by providing an abundant supply on demand.

Considerable advances in treating heart disease could come from using stem cells to repair and regenerate damaged tissues. However, progress in turning the science into medical treatments has been slow.

Two of the big problems are: getting stem cells to make heart cells and then making enough heart cells for medical treatments.

Novathera, which heads one of three major consortia currently supported by the UK Department of Trade and Industry (DTI) under the Technology Programme to develop stem cell technology, has an ambitious plan to help overcome this problem. ‘If stem cell-based therapies are ever to have a significant impact on healthcare, we must abandon the complex, time-consuming and expensive tailor-made route. What we need is an ‘off-the-shelf’ product capable of scale up and turning into cell factories to provide material for medical treatments’, said Gareth Roberts CEO of Novathera.

NovaThera has launched a programme to draw together world-leading groups in Imperial College (UK) and The Texas Heart Institute (US) to confront the challenges in stem cell biology and produce working systems for efficient and reliable large scale cell production – using sophisticated bioprocessor technology, the group intends to develop the world’s first processes for practical manufacture of cells for medical uses.

Professor Dame Julia Polak, from Imperial College London and based at the Chelsea and Westminster Hospital, who leads the research team, says: “This is a very exciting development and could be a huge step towards being able to develop practical approaches to heart repair using cells.”

The project will develop processes to supply large numbers of specialized heart muscle cells and showing that these cells can be safely used to repair damaged heart tissue.

Dr Anne Bishop, lead scientist on the project at Imperial College adds: “Although it will be some years before we can deliver cell therapies as an everyday treatment, this is an important programme to turn this promise into a reality.”

Dr Ed Yeh, Chair, Department of Cardiology at The University of Texas, said: “It is clear that the use of embryonic stem cells in heart repair could provide new therapeutic opportunities and we clinicians need to have as many tools as possible at our disposal if we are ever going to make a significant reduction in the numbers of people dying from heart disease. This allows us to continue the first class research, initially by testing the cells in animal models of heart injury and, finally by carrying out full clinical trials.”

The President-Elect and Medical Director of the Texas Heart Institute, Dr James T Willerson, said: "We are very excited to work with Imperial College/NovaThera Ltd. at the Texas Heart Institute in Houston, Texas on new kinds of stem cell therapy. Working together, I am confident we will find new stem cell therapies that help people with heart and vascular disease.”

The project brings together world class science and to provide an outstanding opportunity to apply regenerative therapies in the treatment of heart disease.

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Notes to editors:

Background on Novathera Ltd.
NovaThera Ltd. (“NovaThera”) is a spin-out of Imperial College London. It specialises in pioneering applications of biomaterials and stem cell biology for regenerative medicine and tissue engineering to provide innovative therapeutic solutions. NovaThera has a relationship with Imperial College to continue commercialisation of the current and future technologies emanating from Tissue Engineering and Regenerative Medicine Centre (“TERM”) of Imperial College London, a world-class research center combining biology, biomaterials and bio-photonics expertise. For more information about NovaThera, please visit http://www.novathera.com.

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.

Background on Imperial College London
Consistently rated in the top three UK university institutions, Imperial College London is a world leading science-based university whose reputation for excellence in teaching and research attracts students (11,000) and staff (6,000) of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and management and delivers practical solutions that enhance the quality of life and the environment - underpinned by a dynamic enterprise culture. Website: www.imperial.ac.uk.

Background Texas Heart Institute
This Institute, under the direction of Dr James T. Willerson, is a non-profit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programmes in research, education and improved patient care. Amongst its many major achievements, in 1962 the Institute was the first in the U.S.A. to carry out a successful heart transplantation. In 2004, it became the first clinical centre to obtain FDA approval for a clinical trial of adult stem cell therapy for congestive heart failure.

Background on Department of Trade and Industry (DTI)

The DTI's Technology Programme comprises two DTI support products, Collaborative Research and Development Grants and Knowledge Transfer Networks. The Government's ten-year Science and Innovation Investment Framework, published in July 2004, reaffirmed the commitment to support businesses investing in new and emerging technologies. Over the period 2005-2008, £320 million is available to businesses in the form of grants to support research and development in the technology area. For further information please go to http://www.dti.gov.uk/technologyprogramme/