MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

NCT ID: NCT04052191

Last Updated: 2024-10-03

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

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Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant blind with dose.

Study Groups

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Low Dose

Low Dose of MCRcI® stem cells.

Group Type EXPERIMENTAL

MCRcI® stem cells

Intervention Type BIOLOGICAL

Intra-Coronary Administration of MCRcI® stem cells

Intermediate Dose

Intermediate Dose of MCRcI® stem cells.

Group Type EXPERIMENTAL

MCRcI® stem cells

Intervention Type BIOLOGICAL

Intra-Coronary Administration of MCRcI® stem cells

High Dose

High Dose of MCRcI® stem cells.

Group Type EXPERIMENTAL

MCRcI® stem cells

Intervention Type BIOLOGICAL

Intra-Coronary Administration of MCRcI® stem cells

Interventions

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MCRcI® stem cells

Intra-Coronary Administration of MCRcI® stem cells

Intervention Type BIOLOGICAL

Other Intervention Names

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stem cells

Eligibility Criteria

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Inclusion Criteria

* Patients with Diffuse Coronary Artery Disease
* Age 20\~80
* Participants have received proper medication
* Canadian Cardiovascular Society class II- IV Angina.

Exclusion Criteria

* Age \<20 or \>80
* Pregnant or breast feeding
* Positive adventitious infection (such as HIV, hepatitis )
* History of Myocardial Infarction within past 3 months
* Severe aortic or mitral valve narrowing
* Short of breath unable to receive PCI examination or treatment
* Malignant tumor
* Hematopoietic dysplasia
* Severe organ disease with less than 1 year of life expectancy
* Chronic kidney disease with CCr\<20ml/min
* Kiney disease on renal dialysis.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Honya Medical Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fang Y Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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HONYA Medical Inc

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Jackson TK Liu, MD

Role: CONTACT

+886921167980

Facility Contacts

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Jackson TK Liu, MD

Role: primary

+88665055006

Other Identifiers

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KCG17121910001

Identifier Type: -

Identifier Source: org_study_id

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