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NCT02941705 · ClinicalTrials.gov registry record · Phase 2
Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFpEF Patients Treated With Allogeneic CDCs
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02941705 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 27 participants.
The verdict
NCT02941705, a Phase 2 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to determine whether treatment of HFpEF patients with intracoronary allogeneic CDCs affects clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics (supine exercise ergometry during right heart catheterization), myocardial interstitial fibrosis (MRI with native T1 mapping and calculation of extracellular volume \[ECV\] after gadolinium administration), macroscopic fibrosis by delayed gadolinium enhancement (DGE), and diastolic function (catheterization, echocardiography, BNP). Treatment of patients with symptomatic hypertensive heart disease-induced HFpEF with allogeneic CDCs will be safe and will improve clinical functional status, exercise tolerance/hemodynamics, myocardial interstitial structure, and diastolic function; the mechanisms underlying these improvements will be reflected in changes in plasma biomarkers that indicate a reduction in pro-inflammatory and pro-fibrotic signaling.
Interventions
- BIOLOGICAL Allogeneic Derived Cells
- BIOLOGICAL Placebo/Control Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02941705
The ClinicalTrials.gov registry entry for NCT02941705 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Allogeneic Derived Cells is the first listed.
NCT02941705 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02941705 about?
NCT02941705 is a clinical study titled "Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFpEF Patients Treated With Allogeneic CDCs". Perform a randomized, double blind, placebo-controlled Phase 2a feasibility study to determine whether treatment of HFpEF patients with intracoronary allogeneic CDCs affects clinical functional status (QOL scores), exercise tolerance (6MHW), exercise hemodynamics (supine exercise ergometry during ri...
What is the current status of trial NCT02941705?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2017-07-12. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT02941705?
The interventions under investigation include: Allogeneic Derived Cells (BIOLOGICAL), Placebo/Control Arm (BIOLOGICAL).
Who is sponsoring clinical trial NCT02941705?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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