Development of a Novel Human In Vitro Sarcoidosis Model

This study is currently recruiting participants.
Verified February 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Elliott Crouser MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01857401
First received: May 2, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

There is currently no experimental model that accurately represents sarcoidosis. The lack of a useful research model significantly slows progress towards developing new treatments for sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will test the model to see if it helps us understand how sarcoidosis develops and if it is useful for testing new treatments.


Condition Intervention
Sarcoidosis
Other: No intervention, observational study only

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Novel Human In Vitro Sarcoidosis Model

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

Blood


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational study
Blood draw only, observational study
Other: No intervention, observational study only
No intervention. We are collecting blood for an ex vivo study

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • sarcoidosis, subjects (18 - 45 years of age), including 30 sarcoidosis, 15 latent TB and 15 healthy controls.

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857401

Contacts
Contact: Elliot Crouser, MD 6147-293-4975 elliot.crouser@osumc.edu

Locations
United States, Ohio
Biomedical Research Tower, 10th floor Recruiting
Columbus, Ohio, United States, 43221
Contact: Elliot Crouser, MD    614-293-4978    elliot.crouser@osumc.edu   
Principal Investigator: Elliot Crouser, MD         
Sponsors and Collaborators
Elliott Crouser MD
Investigators
Principal Investigator: Elliott Crouser, MD Ohio State University
  More Information

No publications provided

Responsible Party: Elliott Crouser MD, Assistant Professor of Internal Medicine, The Ohio State University
ClinicalTrials.gov Identifier: NCT01857401     History of Changes
Other Study ID Numbers: 2012H0073
Study First Received: May 2, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014