Clinical Trial: Revival of Stem Cells in Addison's Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease

Brief Summary: Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.

Detailed Summary:
Sponsor: Newcastle University

Current Primary Outcome: Peak serum Cortisol following ACTH stimulation [ Time Frame: Tested at 20 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in QoL [ Time Frame: 20 weeks ]

Original Secondary Outcome: Same as current

Information By: Newcastle University

Dates:
Date Received: March 9, 2011
Date Started: September 2010
Date Completion:
Last Updated: February 5, 2013
Last Verified: February 2013