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

NCT ID: NCT04695522

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-27

Study Completion Date

2021-10-31

Brief Summary

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Ischemic cardiomyopathy undergoing coronary artery bypass surgery

Detailed Description

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Conditions

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D017202

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group of subjects undergoing cell transplantation

Group Type EXPERIMENTAL

ADR-002K administration

Intervention Type BIOLOGICAL

ADR-002K administration

Group of subjects undergoing sham operation

Group Type SHAM_COMPARATOR

ADR-002K administration

Intervention Type BIOLOGICAL

ADR-002K administration

Interventions

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ADR-002K administration

ADR-002K administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohto Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Osaka University

OTHER

Sponsor Role lead

Responsible Party

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Daisuke Mori

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daisuke Mori, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Osaka University Hospital

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Daisuke Mori, Ph.D

Role: CONTACT

+81-6-6879-3154

Masao Sasai, Ph.D

Role: CONTACT

+81-6-6879-3154

Facility Contacts

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Daisuke Mori, Ph.D

Role: primary

+81-6-6879-3154

Masao Sasai, Ph.D

Role: backup

+81-6-6105-5240

References

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Kawamura T, Yoshioka D, Kawamura A, Misumi Y, Taguchi T, Mori D, Saito S, Yamauchi T, Hata H, Miyagawa S. Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic cardiomyopathy: a phase I clinical trial. J Transl Med. 2024 Dec 2;22(1):1091. doi: 10.1186/s12967-024-05816-1.

Reference Type DERIVED
PMID: 39623426 (View on PubMed)

Other Identifiers

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CVSR0006

Identifier Type: -

Identifier Source: org_study_id

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