The Fertility Show, Manchester Central, 24-25 March 2018
Page URL:

Disappointing results one year into diabetes stem cell trial

9 January 2012
Appeared in BioNews 639

Biotech company Osiris Therapeutics has this month released an optimistic update on its Phase II trial evaluating the use of adult stem cells for the treatment of type 1 diabetes, despite lacking positive results.

The treatment, Prochymal, is a formulation of adult mesenchymal stem cells (MSCs), which Osiris hopes could be used in patients with newly diagnosed type 1 diabetes. The trial aims to assess the safety of the treatment and highlight any positive impacts, such as slowing disease progression.

The trial is using MSCs from unrelated adult donors in 63 paediatric and adult patients. The participants were randomly assigned to receive either Prochymal or a placebo, with neither physicians nor patients aware of what group they were in.

According to Osiris, the treatment did not cause any 'adverse events' and 'no patients experienced a reaction to the infusions despite the cells being unrelated to the recipient, unmatched, and used without immunosuppression'.

However, the treatment failed to achieve its primary endpoint: showing no signs of slowing disease progression at the one year time point. The press release reported a 'trend towards fewer hypoglycemic events for patients treated with Prochymal as compared to controls'. Unfortunately for Osiris, this was one of six secondary endpoints, the rest of which failed. The patients will be followed up for one more year.

Osiris has trialled this stem cell preparation against a number of other conditions, including graft-versus-host disease, cardiac events, cartilage repair and Crohn's disease. As reported online in The Street, all have seen similar results: no adverse effects, but no significant positive effects. This has roused strong criticisms of the trial, and indeed the potentially misleading press release by Osiris giving the impression of success.

Osiris Shows No Reason To Invest In Stem Cell Ideas
Seeking Alpha |  5 January 2012
Osiris Stem Cell Therapy Fails Diabetes Trial
The Street |  3 January 2012
Osiris Therapeutics Provides Update on Groundbreaking Stem Cell Trial for Type 1 Diabetes
Market Watch - Press Release |  3 January 2012
11 March 2013 - by Reuben Harwood 
Genetic analysis of a family predisposed to type 1 diabetes (T1D) has uncovered the first kind of T1D to be caused by a single gene mutation...
21 May 2012 - by Victoria Kay 
The world's first stem cell drug has been approved by Canadian authorities. US biotech company, Osiris Therapeutics, has been given the go-ahead to market its drug, Prochymal, for the treatment of graft-versus-host-disease (GvHD) in children who fail to respond to steroids....
16 January 2012 - by Ayesha Jadoon 
'Re-training' immune cells in people with type 1 diabetes reduces the amount of insulin they need to inject, according to a results from a small clinical trial...
14 November 2011 - by George Frodsham 
Mice that don't produce a certain protein in their fat cells do not develop type 2 diabetes despite an increase in weight, scientists report. In a separate study, the same research group also managed to double the physical performance of mice by removing the same protein from their muscle cells...
10 October 2011 - by Dr Tamara Hirsch 
Mutations in a single gene have been identified as the cause of a severe and life-threatening form of hypoglycaemia...
25 July 2011 - by Julianna Photopoulos 
Funding from private, non-profit, and public sectors will be needed for the UK to maintain its 'world leading' role in regenerative medicine, according to a recent Government strategy report....
21 June 2010 - by Louise Mallon 
A recent study has shown a rare genetic mutation in a single gene is linked to several different autoimmune diseases, including Type 1 diabetes, lupus and rheumatoid arthritis...
Log in to add a Comment.

By posting a comment you agree to abide by the BioNews terms and conditions

Syndicate this story - click here to enquire about using this story.