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Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology

NCT ID: NCT01273857

Last Updated: 2021-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output. Infants with the syndrome generally undergo a staged surgical approach in view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and related single ventricle physiology has improved markedly with advances in medical and surgical therapies, a growing number of infants will ultimately require heart transplantation for end-stage heart failure due to several potential disadvantages include a negative effect on right ventricular function, arrhythmia, additional volume load via regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.

Risk factors for poor outcome of heart transplantation with HLHS and single ventricle physiology are older age at transplantation and previous Fontan operation. New strategies are needed to improve the underlying transplant risks proper for the Fontan failure patients.

Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved cardiac function in patients with ischemic heart disease. In this trial, the investigators aimed to test the safety and feasibility of intracoronary injection of autologous cardiac progenitor cells in patients with HLHS and related single ventricle anomalies and that could improve ventricular function at 3 months' follow up.

Detailed Description

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Autologous cardiac progenitor cells are isolated from patients' own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Conditions

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Hypoplastic Left Heart Syndrome Single Ventricle Heart Failure

Keywords

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Cardiac progenitor cells Cell therapy Hypoplastic Left Heart Syndrome Single Ventricle Norwood Sano modification Glenn Fontan

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Subjects will undergo standard staged-procedures without cell infusion

Group Type SHAM_COMPARATOR

staged shunt procedure

Intervention Type PROCEDURE

Norwood-Glenn, Glenn, or Fontan procedure will be applied

Cell infusion

Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure

Group Type EXPERIMENTAL

Autologous cardiac progenitor cell transplantation

Intervention Type PROCEDURE

Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

staged shunt procedure

Intervention Type PROCEDURE

Norwood-Glenn, Glenn, or Fontan procedure will be applied

Interventions

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Autologous cardiac progenitor cell transplantation

Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Intervention Type PROCEDURE

staged shunt procedure

Norwood-Glenn, Glenn, or Fontan procedure will be applied

Intervention Type PROCEDURE

Other Intervention Names

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Cardiosphere-derived cells

Eligibility Criteria

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Inclusion Criteria

* Infants with hypoplastic left heart syndrome and related single ventricle anomalies undergoing first to third palliative shunt surgeries will be recruited into the study.
* Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.

Exclusion Criteria

* Cardiogenic shock
* Eisenmenger syndrome
* Uncontrollable arrhythmia
* Severe chronic diseases
* Infections
* Cancer
* Unwillingness to participate
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role collaborator

Okayama University

OTHER

Sponsor Role lead

Responsible Party

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Hidemasa Oh, MD

MD., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hidemasa Oh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital

Locations

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Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital

Okayama, , Japan

Site Status

Countries

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Japan

References

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Takehara N, Tsutsumi Y, Tateishi K, Ogata T, Tanaka H, Ueyama T, Takahashi T, Takamatsu T, Fukushima M, Komeda M, Yamagishi M, Yaku H, Tabata Y, Matsubara H, Oh H. Controlled delivery of basic fibroblast growth factor promotes human cardiosphere-derived cell engraftment to enhance cardiac repair for chronic myocardial infarction. J Am Coll Cardiol. 2008 Dec 2;52(23):1858-1865. doi: 10.1016/j.jacc.2008.06.052.

Reference Type BACKGROUND
PMID: 19038683 (View on PubMed)

Tateishi K, Takehara N, Matsubara H, Oh H. Stemming heart failure with cardiac- or reprogrammed-stem cells. J Cell Mol Med. 2008 Dec;12(6A):2217-32. doi: 10.1111/j.1582-4934.2008.00487.x. Epub 2008 Aug 27.

Reference Type BACKGROUND
PMID: 18754813 (View on PubMed)

Tateishi K, Ashihara E, Takehara N, Nomura T, Honsho S, Nakagami T, Morikawa S, Takahashi T, Ueyama T, Matsubara H, Oh H. Clonally amplified cardiac stem cells are regulated by Sca-1 signaling for efficient cardiovascular regeneration. J Cell Sci. 2007 May 15;120(Pt 10):1791-800. doi: 10.1242/jcs.006122.

Reference Type BACKGROUND
PMID: 17502484 (View on PubMed)

Tateishi K, Ashihara E, Honsho S, Takehara N, Nomura T, Takahashi T, Ueyama T, Yamagishi M, Yaku H, Matsubara H, Oh H. Human cardiac stem cells exhibit mesenchymal features and are maintained through Akt/GSK-3beta signaling. Biochem Biophys Res Commun. 2007 Jan 19;352(3):635-41. doi: 10.1016/j.bbrc.2006.11.096. Epub 2006 Nov 27.

Reference Type BACKGROUND
PMID: 17150190 (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 RESULT
PMID: 25403163 (View on PubMed)

Hirai K, Sawada R, Hayashi T, Araki T, Nakagawa N, Kondo M, Yasuda K, Hirata T, Sato T, Nakatsuka Y, Yoshida M, Kasahara S, Baba K, Oh H; TICAP/PERSEUS Study Group. Eight-Year Outcomes of Cardiosphere-Derived Cells in Single Ventricle Congenital Heart Disease. J Am Heart Assoc. 2024 Nov 19;13(22):e038137. doi: 10.1161/JAHA.124.038137. Epub 2024 Nov 11.

Reference Type DERIVED
PMID: 39526355 (View on PubMed)

Sano T, Ousaka D, Goto T, Ishigami S, Hirai K, Kasahara S, Ohtsuki S, Sano S, Oh H. Impact of Cardiac Progenitor Cells on Heart Failure and Survival in Single Ventricle Congenital Heart Disease. Circ Res. 2018 Mar 30;122(7):994-1005. doi: 10.1161/CIRCRESAHA.117.312311. Epub 2018 Jan 24.

Reference Type DERIVED
PMID: 29367212 (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 DERIVED
PMID: 26232942 (View on PubMed)

Other Identifiers

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MHLW10103228

Identifier Type: -

Identifier Source: org_study_id