Phase 1
N=5
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
Dilated Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT03129568 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CDC infusion (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Okayama University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. |
1 | — |
| SECONDARY Change in Ejection Fraction |
4.5 | — |
Summary
A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed as dilated cardiomyopathy.
- Patients aged under 18 years old.
- Cardiac ejection fraction < 40%.
Exclusion Criteria
- Contradiction to cardiac magnetic resonance imaging.
- Cardiogenic shock.
- A patient with unstoppable extracorporeal circulation.
- A patient with lethal, uncontrollable arrhythmia.
- A patient with a complication of coronary artery disease.
- A patient with a complication of brain dysfunction due to circulatory failure.
- A patient with malignant neoplasm.
- A patient with a complication of a serious neurologic disorder.
- A patient with high-grade pulmonary embolism or pulmonary hypertension.
- A patient with high-grade renal failure.
- A patient with multiple organ failure.
- Active infection (including endocarditis).
- Sepsis.
- Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
Data sourced from ClinicalTrials.gov (NCT03129568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.