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Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

NCT ID: NCT03129568

Last Updated: 2021-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-12-09

Brief Summary

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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.

Detailed Description

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Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.

Conditions

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Dilated Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Transcoronary infusion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CDC infusion

CDCs infusion by coronary intervention.

Group Type EXPERIMENTAL

CDC infusion

Intervention Type BIOLOGICAL

Injection of CDCs (0.3 million per kg of body weight).

Interventions

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CDC infusion

Injection of CDCs (0.3 million per kg of body weight).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role collaborator

Okayama University

OTHER

Sponsor Role lead

Responsible Party

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Hidemasa Oh, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shigeru Uemura, M.D., Ph.D.

Role: STUDY_CHAIR

Shonan Tobu Clinic

Locations

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Okayama University Hospital

Okayama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 28052915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26232942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25403163 (View on PubMed)

Hirai K, Ousaka D, Fukushima Y, Kondo M, Eitoku T, Shigemitsu Y, Hara M, Baba K, Iwasaki T, Kasahara S, Ohtsuki S, Oh H. Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy. Sci Transl Med. 2020 Dec 9;12(573):eabb3336. doi: 10.1126/scitranslmed.abb3336.

Reference Type RESULT
PMID: 33298561 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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01F1701003

Identifier Type: -

Identifier Source: org_study_id