Intra-coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease (CAD) and non-candidates for coronary artery intervention

Intra-coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease and non-candidates for coronary artery intervention: a randomized placebo controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26002902

Enrollment

Registered

2013-09-11

Start date

2013-01-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ischemic heart disease Circulatory System Chronic ischaemic heart disease, unspecified

Interventions

Intervention: autologous endothelial progenitor cells (5x10^7) Control: optimal medical therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with age between 20-80 years-old who have angina pectoris resulted in severely and diffusely atherosclerotic obstructive CAD with refractory to optimal medication are not the candidates for both PCI or CABG

Exclusion criteria

Exclusion criteria: 1. Age less than 20 years or more than 80 years 2. Pregnant women 3. Patients with adventitious agents (like HIV, Hepatitis viruses) 4. Myocardial infarction (MI) within 3 months 5. Aortic stenosis or mitral stenosis 6. Congestive heart failure, New York Heart Association functional class (NYHA Fc.)IV 7. Malignancy or other severe disease with life span less than one year 8. Chronic kidney disease with CCr<20ml/min and end stage renal disease

Design outcomes

Primary

Measure	Time frame
The safety of intracoronary delivery of autologous CD34+ cells in patients with severely and diffusely atherosclerotic obstructive CAD who are not candidates for PCI and CABG and unsatisfactory medical treated result. Clinical follow-up (1 week, 1 month, 3 months, 6 months, 9 months, 12 months).	—

Secondary

Measure	Time frame
1. The efficacy of autologous intracoronary CD34+ cell therapy on improving degree of Angina Pectoris. 2. Quality of Life 3. LV function 4. Clinical Outcome in patients with severediffuse CAD Methods and time points: 1. Canadian Cardiovascular Society Angina Class and New York Heart Association functional class: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 2. Electrocardiogram: per day during hospitalization, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 3. Echocardiography: 1 month, 3months, 6months. 4. Tl-201: 6 months. 5. Cardiac MRI: 6 months and 12 months.	—

Measure

Time frame

1. The efficacy of autologous intracoronary CD34+ cell therapy on improving degree of Angina Pectoris. 2. Quality of Life 3. LV function 4. Clinical Outcome in patients with severediffuse CAD Methods and time points: 1. Canadian Cardiovascular Society Angina Class and New York Heart Association functional class: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 2. Electrocardiogram: per day during hospitalization, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 3. Echocardiography: 1 month, 3months, 6months. 4. Tl-201: 6 months. 5. Cardiac MRI: 6 months and 12 months.

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Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026