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

Primary Purpose

Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Autologous cardiac progenitor cell transplantation
staged shunt procedure
Sponsored by
Okayama University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring Cardiac progenitor cells, Cell therapy, Hypoplastic Left Heart Syndrome, Single Ventricle, Norwood, Sano modification, Glenn, Fontan

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Cell infusion

Arm Description

Subjects will undergo standard staged-procedures without cell infusion

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

Outcomes

Primary Outcome Measures

Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells
Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion. The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.

Secondary Outcome Measures

Serious Adverse Events
The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.

Full Information

First Posted
January 10, 2011
Last Updated
November 23, 2021
Sponsor
Okayama University
Collaborators
National Cerebral and Cardiovascular Center, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01273857
Brief Title
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Acronym
TICAP
Official Title
Phase I Study of Cardiac Progenitor Cell Therapy in Patients With Single Ventricle Physiology
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okayama University
Collaborators
National Cerebral and Cardiovascular Center, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
Keywords
Cardiac progenitor cells, Cell therapy, Hypoplastic Left Heart Syndrome, Single Ventricle, Norwood, Sano modification, Glenn, Fontan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Subjects will undergo standard staged-procedures without cell infusion
Arm Title
Cell infusion
Arm Type
Experimental
Arm Description
Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
Intervention Type
Procedure
Intervention Name(s)
Autologous cardiac progenitor cell transplantation
Other Intervention Name(s)
Cardiosphere-derived cells
Intervention Description
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
Intervention Name(s)
staged shunt procedure
Intervention Description
Norwood-Glenn, Glenn, or Fontan procedure will be applied
Primary Outcome Measure Information:
Title
Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells
Description
Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion. The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
Time Frame
3 months to 1 year after cell transplantation
Secondary Outcome Measure Information:
Title
Serious Adverse Events
Description
The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.
Time Frame
3 months to 1 year after cell transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hidemasa Oh, M.D., Ph.D.
Organizational Affiliation
Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19038683
Citation
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.
Results Reference
background
PubMed Identifier
18754813
Citation
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.
Results Reference
background
PubMed Identifier
17502484
Citation
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.
Results Reference
background
PubMed Identifier
17150190
Citation
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.
Results Reference
background
PubMed Identifier
25403163
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.
Results Reference
result
PubMed Identifier
29367212
Citation
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.
Results Reference
derived
PubMed Identifier
26232942
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.
Results Reference
derived
Links:
URL
http://shin-iryo.hospital.okayama-u.ac.jp/center/index3.html#english
Description
Center for Innovative Clinical Medicine

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

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