NCT01371526

Revival of Stem Cells in Addison's Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Newcastle University · Academic / Other
• Sex: All
• Age: 16 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenal Failure

Interventions

Type	Name	Description
DRUG	depot tetracosactide	1mg, 3x weekly by sc injection

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-06-13
• Last updated: 2013-02-06

Locations

1 site across 1 country: United Kingdom