Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
NCT ID: NCT02781922
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2016-06-30
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Autologous cardiac stem cells (JRM-001)
Autologous cardiac stem cells (JRM-001)
3x 10\^5 cells/kg, single treatment
Usual care
No interventions assigned to this group
Interventions
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Autologous cardiac stem cells (JRM-001)
3x 10\^5 cells/kg, single treatment
Eligibility Criteria
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Inclusion Criteria
* EF(%) by echocardiography ≤ 55%
* Able to obtain written informed consent of participation in the study by a parent of the patient
Exclusion Criteria
* 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
0 Years
6 Years
ALL
No
Sponsors
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Metcela Inc.
INDUSTRY
Responsible Party
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Locations
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Kanagawa Children's Medical Center
Kanagawa, , Japan
Okayama University Hospital
Okayama, , Japan
Saitama Prefectural Children's Medical Center
Saitama, , Japan
Shizuoka Children's Hospital
Shizuoka, , Japan
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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001-CLJ-001
Identifier Type: -
Identifier Source: org_study_id
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