Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study
Who is this study for? Patients with Hypoplastic Left Heart Syndrome
What treatments are being studied? Autologous Cardiac Stem Cells (JRM-001)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Japan
Kanagawa Children's Medical Center
RECRUITING
Kanagawa
Okayama University Hospital
RECRUITING
Okayama
Saitama Prefectural Children's Medical Center
RECRUITING
Saitama
Shizuoka Children's Hospital
RECRUITING
Shizuoka
Contact Information
Primary
Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)
info@j-rm.com
Time Frame
Start Date: 2016-06
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
Experimental: Autologous cardiac stem cells (JRM-001)
No_intervention: Usual care
Authors
Related Therapeutic Areas
Sponsors
Leads: Metcela Inc.