Development of a Novel Human In Vitro Sarcoidosis Model
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|ClinicalTrials.gov Identifier: NCT01857401|
Recruitment Status : Unknown
Verified September 2014 by Elliott Crouser MD, The Ohio State University.
Recruitment status was: Recruiting
First Posted : May 20, 2013
Last Update Posted : September 4, 2014
|Condition or disease||Intervention/treatment|
|Sarcoidosis||Other: No intervention, observational study only|
Sarcoidosis is a systemic granulomatous disease of unknown cause, most commonly affecting the lungs, which tends to afflict young adults in the prime of their lives. Recent data indicating that sarcoidosis mortality rates are rising in the U.S. (1) and Europe (2) highlight the inadequacy of current therapies. As noted in a recent NIH-sponsored sarcoidosis workshop, the lack of relevant animal, computer or in vitro models represents a bottleneck for progress towards understanding disease mechanisms and developing highly effective sarcoidosis treatments (3). The lack of useful disease models likely contributes to the current lack (zero) of investigator-initiated (RO1) projects supporting sarcoidosis research.
The long-term goal of this proposal is to develop a novel human sarcoidosis research model to fill the current void in the field, thereby expediting exploration of basic disease mechanisms and pre-clinical testing of novel therapies. The objective of this application, which is the first step towards achieving the long-term goal, is to develop a novel in vitro human granuloma model to represent abnormal granuloma formation in the context of sarcoidosis. In this regard, a growing body of evidence indicates that mycobacterial antigens are commonly harbored in sarcoidosis tissues, to which these patients are sensitized (4, 5). Our central hypothesis is that the pathological mechanisms of sarcoidosis can be modeled in vitro, as represented by abnormal granuloma formation in response to mycobacterial and other ubiquitous environmental antigens. The feasibility of our proposed model is supported by preliminary studies showing that subjects sensitized to Mycobacterium tuberculosis antigens (latent TB tuberculosis with a positive TB skin test) form well-organized granulomas readily in response to challenge with TB antigens, compared to healthy controls. This project is highly innovative and we feel has an excellent likelihood of leading to a critical breakthrough in the field of sarcoidosis research.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Development of a Novel Human In Vitro Sarcoidosis Model|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2015|
Blood draw only, observational study
Other: No intervention, observational study only
No intervention. We are collecting blood for an ex vivo study
- Sarcoidosis patients, volunteers with latent TB, and healthy volunteer subjects will be recruited to donate peripheral blood for isolation of peripheral blood mononuclear cells. [ Time Frame: 2-4 years ]We hypothesize that patients with the active sarcoidosis phenotype will exhibit accelerated granuloma formation with higher IL-10(IL Interleukin)and IL-4 expression relative to patients with the self-limited sarcoidosis phenotype
Biospecimen Retention: Samples With DNA
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): NCT01857401
|Contact: Elliot Crouser, MDfirstname.lastname@example.org|
|United States, Ohio|
|Biomedical Research Tower, 10th floor||Recruiting|
|Columbus, Ohio, United States, 43221|
|Contact: Elliot Crouser, MD 614-293-4978 email@example.com|
|Principal Investigator: Elliot Crouser, MD|
|Principal Investigator:||Elliott Crouser, MD||Ohio State University|