Revival of Stem Cells in Addison's Study

Phase 4

Completed

• Conditions: Adrenal Failure
• Interventions: Drug: depot tetracosactide

• Registration Number: NCT01371526
• Lead Sponsor: Newcastle University

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 Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-13
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Established autoimmune adrenal failure for >1yr age 16 to 65

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Exclusion Criteria

• Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
• Asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease
• Pregnancy, breast feeding or plan for pregnancy within 9 months
• Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.)
• Known hypersensitivity or allergy to Synacthen

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synacthen	depot tetracosactide	active treatment

Primary Outcome Measures

Name	Time	Method
Peak serum Cortisol following ACTH stimulation	Tested at 20 weeks

Secondary Outcome Measures

Name	Time	Method
Change in QoL	20 weeks

Trial Locations

Locations (1)

Newcastle University; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom