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10 April 2013

Stem cell study sparks new Crohn’s hope

WA Health scientists believe they are on the brink of a major breakthrough in the treatment of people with Crohn's Disease.

Their excitement follows the extraordinary results of a Royal Perth Hospital-led study that is investigating the use of adult stem cells to treat patients with the potentially debilitating gastro-intestinal condition.

Marian Sturm, principal scientist with Royal Perth Hospital's Cell and Tissue Therapies WA Unit says that although the study is still in its early stages, its initial findings are extremely encouraging with 80 per cent of participants responding positively to the treatment and more than half going into clinical remission.

The study is being led by RPH gastroenterologist, Dr Geoff Forbes.

Dr Sturm said that to date, 18 people had taken part in the phase two study. All were severe cases for whom existing therapies for Crohn's Disease had failed.

"To achieve an 80 per cent clinical response, particularly in such severe patients, is pretty amazing," Dr Sturm said.

Study participants were given the cell treatment intravenously, once a week over a period of four weeks. Each treatment consisted of mesenchymal stromal cells (MSC), obtained from the bone marrow of donors and culture-expanded in RPH's Cell and Tissue Therapies WA manufacturing unit.

Dr Sturm said MSCs were versatile cells with unique properties that made them particularly special. These included that they:

  • were universal donor cells, which meant that anyone's cells could be given to any other person, without the need for tissue matching
  • home to sites of inflammation.

In the MSC study, patients' response to the cell therapy was gauged using:

  • endoscopic assessment
  • Crohn's Disease Activity Index (CDAI) scores.

Participants in RPH's MSC study had initial CDAI scores ranging from 250 to 600, meaning they had moderate to severe activity of their disease. Following the cell treatment, 50 per cent recorded scores lower than 150 – technically putting them into remission and 47 per cent showed significant improvement on endoscopic examination. No adverse affects were noted.

A team of RPH doctors, scientists and nurses instigated the MSC study. The hospital is the lead centre of the project which is being undertaken nationally across five hospitals — RPH and Sir Charles Gairdner Hospital in Perth, The Queen Elizabeth in Adelaide, The Alfred in Melbourne, and Concord Hospital in Sydney.

Dr Forbes said that having demonstrated the new therapy's effectiveness and safety in a small number of patients, the researchers were keen to secure further money to enable progression to a phase three trial.

Crohn's Disease is a form of inflammatory bowel disease that can affect any part of the gastro-intestinal tract. About 28,000 Australians have the condition and about 800 new cases are diagnosed annually, mostly in young adults.

Crohn's Disease commonly causes abdominal pain, diarrhoea and bleeding into the bowel and treatment is usually with medications that suppress activity of the immune system. Patients who do not benefit from anti-tumour necrosis factor (anti-TNF) therapy — used when Crohn's Disease has not been controlled by lesser immune suppressing treatments — will often require surgery.

Dr Sturm revealed that MSCs were being trialled for a range of other medical applications including the treatment of patients with various other auto immune conditions, for donor organ recipients with graft rejection and for patients with graft versus host disease (GVHD), a complication of bone marrow transplantation.

Funding for the phase 2 stage of the study has come from international and national funding agencies including the Broad Medical Research Program of Los Angeles and Australian-based funding agency, Therapeutic Innovations Australia.

Media contact: (08) 9222 4333

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