ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Ischemic cardiomyopathy undergoing coronary artery bypass surgery

Study Overview

• Status: Recruiting
• Conditions: D017202
• Intervention / Treatment: Biological: ADR-002K administration

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Daisuke Mori, Ph.D; Phone Number: +81-6-6879-3154; Email: daimolion@gmail.com
• Study Contact Backup: Name: Masao Sasai, Ph.D; Phone Number: +81-6-6879-3154; Email: sasai-masao@tissue.med.osaka-u.ac.jp

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 5650871
      • Recruiting
      • Osaka University Hospital
      • Contact: Daisuke Mori, Ph.D; Phone Number: +81-6-6879-3154; Email: daimolion@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3. Others

Exclusion Criteria:

1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3. Others

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group of subjects undergoing cell transplantation	Biological: ADR-002K administration; ADR-002K administration
Sham Comparator: Group of subjects undergoing sham operation	Biological: ADR-002K administration; ADR-002K administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse event	Safety assessment related to adverse events and this product	26 weeks
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery	Efficacy (Exploratory)	26 weeks
Number of complication associated with drug administration method	Feasibility of drug administration method	26 weeks

Collaborators and Investigators

• Sponsor: Osaka University
• Collaborators: Rohto Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Daisuke Mori, Ph.D, Osaka University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: January 2, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery bypass; Regenerative medicine; Adipose-derived mesenchymal stem cells; Ischemic cardiomyopathy; Spray method
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: CVSR0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No