Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

November 23, 2021 updated by: Hidemasa Oh, MD, Okayama University

Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.

The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Okayama, Japan, 700-8558
        • Okayama University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: Age is 0 year or more and 20 years or less at the time of enrollment.
  2. The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
  3. The ventricular ejection fraction <60%.

Exclusion Criteria:

  1. Cardiogenic shock
  2. A patient with unstoppable extracorporeal circulation
  3. A patient with lethal, uncontrollable arrhythmia
  4. A patient with a complication of coronary artery disease
  5. A patient with a complication of brain dysfunction due to circulatory failure
  6. A patient with malignant neoplasm
  7. A patient with a complication of serious neurologic disorder
  8. A patient with high-grade pulmonary embolism or pulmonary hypertension
  9. A patient with high-grade renal failure
  10. A patient with multiple organ failure
  11. Active infection (including endocarditis)
  12. Sepsis
  13. Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control

(Stage 1) No active intervention after standard surgical treatment

(Stage 2) Rescuing transplantation by cardiac progenitor cell infusion is applicable in patients, along with their written consent, 4 months after palliations who were assigned as control group in stage 1.
Genetic: Cardiac progenitor cell infusion

(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group

(Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.
ACTIVE_COMPARATOR: Cardiac progenitor cell infusion
(Stage 1) single dose, intracoronary infusion of 0.3 million cells/kg cardiac progenitor cells
Genetic: Cardiac progenitor cell infusion

(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group

(Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: 3 Months
The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: 12 Months
The secondary outcome measure is to determine the cardiac function improvements by three different imaging modalities at 12 months after treatment.
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms
Time Frame: 3 and 12 Months
Clinical symptoms and BNP levels will be assessed at 3- and 12-months after treatment and compared with control group.
3 and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama University

Collaborators

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

Investigators

  • Principal Investigator: Hidemasa Oh, M.D., Ph.D., Okayama University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (ESTIMATE)

April 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0329-18
  • MHLW25040101 (OTHER_GRANT: MHLW25040101)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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