- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01371526
Revival of Stem Cells in Addison's Study (RoSA)
February 5, 2013 updated by: SHS Pearce, Newcastle University
Revival of Autochthonous Adrenocortical Stem Cells in Autoimmune Addison's Disease
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 3BZ
- Newcastle University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 66 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Synacthen
active treatment
|
1mg, 3x weekly by sc injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak serum Cortisol following ACTH stimulation
Time Frame: Tested at 20 weeks
|
Tested at 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in QoL
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon H Pearce, MD, Newcastle University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
March 9, 2011
First Submitted That Met QC Criteria
June 9, 2011
First Posted (Estimate)
June 13, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2013
Last Update Submitted That Met QC Criteria
February 5, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RoSAv1.2:04_10: R&D#5252
- 2009-018074-56 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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