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NCT01711593 · ClinicalTrials.gov registry record · Phase 1
Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma
A Phase 1 study of Asthma and Allergies, sponsored by Andrew D. Luster, M.D.,Ph.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01711593: Completed Phase 1 study of Asthma and Allergies, sponsored by Andrew D. Luster, M.D.,Ph.D..
NCT01711593 is a Phase 1 study of Asthma and Allergies that has completed, run by Andrew D. Luster, M.D.,Ph.D.. The registered enrollment target is 43 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01711593, a Phase 1 study of Asthma and Allergies, has completed, sponsored by Andrew D. Luster, M.D.,Ph.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize that much remains to be learned about the behavior of T effector and T regulatory cells in allergic disease. Furthermore, the investigators hypothesize that novel mechanisms of allergic tolerance may exist, and elucidation of these mechanisms may provide insights into novel therapeutic strategies to control allergic diseases. The investigators will investigate the capacity for T cell tolerance induction in allergic subjects by a novel type of immune tolerizing dendritic cell (it-DC). The investigators will assess whether in vitro generated it-DCs have the capacity to induce antigen-specific T regulatory cells and suppress allergen-specific T effector cell function in vitro. Standardized Cat Allergen extract and Dust Mite Allergens will be used to generate changes in the airways that occur during exposure to allergen. For this investigation, the route of administration will be topical application of the titrated allergen to a bronchoscopically isolated subsegment of one lobe of one lung. The dose of biologic will be determined from prior skin-prick testing.
Primary Outcome
We will generate induced tolerogenic dendritic cells (it-DCs) in vitro from peripheral blood monocytes and dendritic cells isolated from each allergic asthmatic subject and assess their capacity to (a) attenuate effector CD4+ T cell (Teff) responses and/or (b) induce T regulatory (Treg) cells from Teff cells as well as CD4+ naïve and memory T cells. Attenuation of T cell responses (a) will be assessed by proliferation assays and cytokine production. Moreover, in order to evaluate the functionali
Interventions
- PROCEDURE Phlebotomy
- BIOLOGICAL Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT01711593 record still lists
NCT01711593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Phlebotomy is the first listed.
NCT01711593 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01711593 about?
NCT01711593 is a clinical study titled "Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma". Despite advances in medications, allergic diseases, including allergic asthma continue to rise in prevalence. For this reason, there is a need for a better understanding of the mechanisms of allergic diseases and novel insights into modulating allergic inflammation. The investigators hypothesize tha...
What is the current status of trial NCT01711593?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2013-01. Estimated completion is 2016-09.
What conditions does trial NCT01711593 study?
This clinical trial studies the following conditions: Asthma, Allergies.
What interventions are being tested in trial NCT01711593?
The interventions under investigation include: Phlebotomy (PROCEDURE), Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage (BIOLOGICAL).
Who is sponsoring clinical trial NCT01711593?
This trial is sponsored by Andrew D. Luster, M.D.,Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01711593 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01711593's enrollment target sits among peer trials
43 277th of 374 higher than 96 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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