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New treatment option for Hypoplastic Left Heart Syndrome
Official title Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
ClinicalTrials.gov ID: NCT02781922
What this study is testing
What is Autologous cardiac stem cells (JRM-001)?
Autologous cardiac stem cells (JRM-001) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hypoplastic left heart syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join if
- Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- EF(%) by echocardiography ≤ 55%
- Able to obtain written informed consent of participation in the study by a parent of the patient
You likely can't join if
- Known medical history of cardiogenic shock
- Lethal, uncontrollable arrhythmia
- Complication of coronary artery disease
- Eisenmenger syndrome
- Complication of brain dysfunction due to circulatory failure
- Malignant neoplasm
See the full eligibility criteria
- Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- EF(%) by echocardiography ≤ 55%
- Able to obtain written informed consent of participation in the study by a parent of the patient
- Known medical history of cardiogenic shock
- Lethal, uncontrollable arrhythmia
- Complication of coronary artery disease
- Eisenmenger syndrome
- Complication of brain dysfunction due to circulatory failure
- Malignant neoplasm
- Complication of severe neurologic disorder
- Severe pulmonary embolism or pulmonary hypertension
- Severe renal failure
- Multiple organ failure
- Active infection (including endocarditis)
- Sepsis
- Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)
- Known history of hypersensitivity to anti-infective drugs
- Inability to complete the protocol treatment and baseline to follow-up examinations
The study team makes the final eligibility decision.
Where it's taking place
- Kanagawa, Japan
- Okayama, Japan
- Saitama, Japan
- Shizuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kanagawa, Japan; Okayama, Japan; Saitama, Japan; Shizuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.