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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02781922
Other study ID # 001-CLJ-001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 2016
Est. completion date May 2023

Study information

Verified date September 2022
Source Metcela Inc.
Contact Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)
Email info@j-rm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 6 Years
Eligibility Inclusion 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 Exclusion Criteria: - 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

Study Design


Intervention

Genetic:
Autologous cardiac stem cells (JRM-001)
3x 10^5 cells/kg, single treatment

Locations

Country Name City State
Japan Kanagawa Children's Medical Center Kanagawa
Japan Okayama University Hospital Okayama
Japan Shizuoka Children's Hospital Shizuoka

Sponsors (1)

Lead Sponsor Collaborator
Metcela Inc.

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Ishigami S, Ohtsuki S, Eitoku T, Ousaka D, Kondo M, Kurita Y, Hirai K, Fukushima Y, Baba K, Goto T, Horio N, Kobayashi J, Kuroko Y, Kotani Y, Arai S, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Circ Res. 2017 Mar 31;120(7):1162-1173. doi: 10.1161/CIRCRESAHA.116.310253. Epub 2017 Jan 4. — View Citation

Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17. — View Citation

Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ejection fraction (EF(%)) assessed by MRI from baseline Baseline, 6 and 12 months
Secondary Change in EF(%) assessed by echocardiograms from baseline Screening, Baseline, 3, 6 and 12 months
Secondary Change in EF(%) assessed by cardiac catheterization from baseline Baseline, 6 and 12 months
Secondary Change in Ea/Ees assessed by cardiac catheterization from baseline Baseline, 6 and 12 months
Secondary Change in Ventricular Stiffness assessed by cardiac catheterization from baseline Baseline, 6 and 12 months
Secondary Change in heart failure index from baseline Baseline, 3, 6 and 12 months
Secondary Change in Quality of Life (QOL) index from baseline Baseline, 6 and 12 months
Secondary Number of adverse events Up to 12 months
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