Revival of Stem Cells in Addison's Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Adrenal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Synacthen

active treatment

Group Type EXPERIMENTAL

depot tetracosactide

Intervention Type DRUG

1mg, 3x weekly by sc injection

Interventions

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depot tetracosactide

1mg, 3x weekly by sc injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No