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NCT03145298 · ClinicalTrials.gov registry record · Phase 1
ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy
A Phase 1 study of Pulmonary Arterial Hypertension PAH, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03145298: Completed Phase 1 study of Pulmonary Arterial Hypertension PAH, sponsored by Cedars-Sinai Medical Center.
NCT03145298 is a Phase 1 study of Pulmonary Arterial Hypertension PAH that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 26 participants, below the 43-participant average among 5 other Pulmonary Arterial Hypertension PAH trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03145298, a Phase 1 study of Pulmonary Arterial Hypertension PAH, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure. Even with substantial pharmacologic advances in the modern treatment era, survival still remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest that the administration of allogeneic CDCs have the potential to reduce adverse arteriolar remodeling in PAH which was the basis for the approved investigational new drug (IND). The use of CDCs as an adjunctive therapy in patients comprising 4 sub-groups of patients with PAH in which inflammation and immune dysfunction are key pathophysiologic drivers of PAH.
Primary Outcome
* Determination of Gas Exchange: Significant hypoxemia within the 1st 72 hours following the infusion of CAP-1002 cells as determined by arterial blood gas analysis or pulse oximetry on or off O2, which is a distinct change from values obtained at screening. (PaO2 \< 55mmHg; SPO2 \< 85%). * Determination of Hemodynamics: Significant tachycardia and hypotension; while PA cath in-situ: fall in cardiac output; significant rise in PA systolic pressure, mean right atrial pressure. Note, hemodynamic m
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Allogeneic Human Cardiosphere-Derived Stem Cells
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT03145298 record still lists
NCT03145298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 43-participant average among 5 other Pulmonary Arterial Hypertension PAH trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension PAH appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03145298 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03145298 about?
NCT03145298 is a clinical study titled "ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy". Pulmonary Arterial Hypertension or PAH is a progressive condition for which there is no cure. Even with substantial pharmacologic advances in the modern treatment era, survival still remains unacceptably poor, as reported in large PAH registries. Preclinical studies suggest that the administration o...
What is the current status of trial NCT03145298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-10-01. Estimated completion is 2023-03-31.
What conditions does trial NCT03145298 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension PAH.
What interventions are being tested in trial NCT03145298?
The interventions under investigation include: Placebo (BIOLOGICAL), Allogeneic Human Cardiosphere-Derived Stem Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03145298?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03145298 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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