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Completed

NCT Number: NCT01371526

Revival of Stem Cells in Addison's Study

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.

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Key information

Conditions

Adrenal Failure Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Autoimmune Diseases Endocrine System Diseases Immune System Diseases

Age range

16 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE1 3BZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

depot tetracosactide

Drug

1mg, 3x weekly by sc injection

Primary outcomes

  1. Peak serum Cortisol following ACTH stimulation

    Time frame: Tested at 20 weeks

Secondary outcomes

  1. Change in QoL

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Registry information

Official study title

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

Acronym: RoSA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2011
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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