Trial Outcomes & Findings for Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology (NCT NCT01273857)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

3 months to 1 year after cell transplantation

Results posted on

2021-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Control Subjects will undergo standard staged-procedures without cell infusion staged shunt 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 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. staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=7 Participants Subjects will undergo standard staged-procedures without cell infusion staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied	Cell Infusion n=7 Participants Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure 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. staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied	Total n=14 Participants Total of all reporting groups
Age, Continuous	1.5 years STANDARD_DEVIATION 1.7 • n=5 Participants	2.1 years STANDARD_DEVIATION 1.2 • n=7 Participants	1.7 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Japan	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months to 1 year after cell transplantation

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.

Outcome measures

Outcome measures
Measure	Control n=7 Participants Subjects will undergo standard staged-procedures without cell infusion staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied	Cell Infusion n=7 Participants Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure 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. staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied
Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells	0 participants	0 participants

SECONDARY outcome

Timeframe: 3 months to 1 year after cell transplantation

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

Outcome measures

Outcome measures
Measure	Control n=7 Participants Subjects will undergo standard staged-procedures without cell infusion staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied	Cell Infusion n=7 Participants Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure 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. staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied
Serious Adverse Events	0 participants	0 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cell Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Hidemasa Oh

Okayama University Hospital

Phone: +81-086-235-6506

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place