NCT03351400

Brief Summary

The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

4.3 years

First QC Date

November 14, 2017

Last Update Submit

March 17, 2021

Conditions

Chronic Heart FailureOld Myocardial Infarction

Keywords

cardiac stem cellsc-kit

Outcome Measures

Primary Outcomes (1)

  • Monitoring adverse events

    Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism

    2 years

Secondary Outcomes (8)

  • NYHA classification

    2 years

  • Serum NT-proBNP

    2 years

  • Electrocardiogram

    2 years

  • Chest X-ray

    2 years

  • Cardiopulmonary exercise test

    2 years

  • +3 more secondary outcomes

Study Arms (1)

Treatment group

EXPERIMENTAL

Stem cells administered to participants

Biological: Stem cells administered to participants

Interventions

Stem cells administered to participantsBIOLOGICAL

Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.

Treatment group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult with ability to provide informed consent.
  • Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
  • Scheduled for elective surgical revascularization within 2 months.

You may not qualify if:

  • Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
  • Diabetic HbA1c greater than 8.5%.
  • Pregnant women.
  • Scheduled for additional interventions including ventriculoplasty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakakibara Heart Institute

Tokyo, 183-0003, Japan

Location

Related Publications (1)

  • Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.

    PMID: 22965994BACKGROUND

MeSH Terms

Conditions

Piebaldism

Condition Hierarchy (Ancestors)

AlbinismEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsSkin Diseases, GeneticHypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 22, 2017

Study Start

November 15, 2017

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

JP(1)