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Revival of Stem Cells in Addison's Study (RoSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371526
First Posted: June 13, 2011
Last Update Posted: February 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SHS Pearce, Newcastle University
  Purpose
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.

Condition Intervention Phase
Adrenal Failure Drug: depot tetracosactide Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease

Resource links provided by NLM:


Further study details as provided by SHS Pearce, Newcastle University:

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

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

Enrollment: 13
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synacthen
active treatment
Drug: depot tetracosactide
1mg, 3x weekly by sc injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 66 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371526


Locations
United Kingdom
Newcastle University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 3BZ
Sponsors and Collaborators
Newcastle University
Investigators
Principal Investigator: Simon H Pearce, MD Newcastle University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SHS Pearce, Professor of Endocrinology, Newcastle University
ClinicalTrials.gov Identifier: NCT01371526     History of Changes
Other Study ID Numbers: RoSAv1.2:04_10: R&D#5252
2009-018074-56 ( EudraCT Number )
First Submitted: March 9, 2011
First Posted: June 13, 2011
Last Update Posted: February 6, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Cosyntropin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs