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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SHS Pearce, Newcastle University
ClinicalTrials.gov Identifier:
NCT01371526
First received: March 9, 2011
Last updated: February 5, 2013
Last verified: February 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Newcastle University:

Primary Outcome Measures:
  • Peak serum Cortisol following ACTH stimulation [ Time Frame: Tested at 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in QoL [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 66 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Newcastle University

Additional 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
Study First Received: March 9, 2011
Last Updated: February 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014