Trial Outcomes & Findings for Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy (NCT NCT03129568)

NCT ID: NCT03129568

Last Updated: 2021-11-26

Results Overview

Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, 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: 5 participants
• Primary outcome timeframe: 6 months after CDC treatment
• Results posted on: 2021-11-26

Participant Flow

Participant milestones

Measure	CDC Infusion CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight).
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Baseline characteristics by cohort

Measure	CDC Infusion n=5 Participants CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight).
Age, Continuous	11.4 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Cardiac Function	28.5 percentage of baseline ejection fraction STANDARD_DEVIATION 10.7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months after CDC treatment

Population: Adverse events

Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.

Outcome measures

Measure	CDC Infusion n=5 Participants CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight).
Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.	1 Participants

SECONDARY outcome

Timeframe: 6 months after protocol treatment

Population: Changes in cardiac function

To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up.

Outcome measures

Measure	CDC Infusion n=5 Participants CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight).
Change in Ejection Fraction	4.5 percentage of ejection fraction Standard Deviation 10.2

Adverse Events

CDC Infusion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	CDC Infusion n=5 participants at risk CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight).
Cardiac disorders heart failure	20.0% 1/5 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders infection	20.0% 1/5 • Number of events 1 • 1 year
Cardiac disorders ischemic event	20.0% 1/5 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hidemasa Oh

Okayama University Hospital

Phone: 086-235-6506

Email: hidemasa@okayama-u.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place