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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: Completed Phase 2 study, sponsored by Cedars-Sinai Medical Center.
NCT02941705 is a Phase 2 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
any subjects experiencing any safety related events during or post intracoronary delivery and during the follow up period. Safety outcomes will be measured through TIMI flow 0-2, acute myocarditis within one month of intracoronary infusion, ventricular tachycardia or ventricular fibrillation within 72 hours of intracoronary infusion, sudden unexpected death within 72 hours of intracoronary infusion defined as occurring 1 hour within in symptom onset or witnessed death in a subject previously ob
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 |
What the finished NCT02941705 record still lists
NCT02941705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Allogeneic Derived Cells is the first listed.
NCT02941705 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02941705's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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