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

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 randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72853206

Enrollment

Registered

2012-02-17

Start date

2011-12-02

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

Intra-coronary delivery of autologous CD34+ cells are performed in our cardiac catheterization laboratory at day 5 during hospitalization. While one group will receive 1x107 CD34+ cells , the other gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20-80 2. Have angina pectoris resulted in severely and diffusely atherosclerotic-obstructive CAD with refractory to optimal medication not the candidates for both PCI or CABG

Exclusion criteria

Exclusion criteria: 1. Age 80 years 2. Pregnant women 3. Patients with adventitious agents [like:Human immunodeficiency virus (HIV), Hepatitis viruses] 4. Recent myocardial infarction (MI) within 3 months 5. Aortic stenosis or mitral stenosis 6. Congestive heart failure 7. New York Heart Association Functional Class IV (NYHA Fc.IV) 8. Malignancy or other severe disease with life span less than one year 9. Chronic kidney disease with creatinine clearance (CCr) <20ml/min and end stage renal disease

Design outcomes

Primary

Measure	Time frame
The safety of intra-coronary 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 Patients will be monitored for any severe adverse events (mortality, malignant arrhythmia, stroke, myocardial infarction and re-admission for congestive heart failure) during hospitalization and follow-up at OPD in the 1st week, 1st month, and per 3 months for one year after therapy.	—

Measure

Time frame

The safety of intra-coronary 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 Patients will be monitored for any severe adverse events (mortality, malignant arrhythmia, stroke, myocardial infarction and re-admission for congestive heart failure) during hospitalization and follow-up at OPD in the 1st week, 1st month, and per 3 months for one year after therapy.

—

Secondary

Measure	Time frame
1. The efficacy and optimal dose of autologous intra-coronary CD34+ cell therapy on improving degree of angina pectoris 2. Quality of Life - Short Form (SF-36) 3. LV Function 4. Clinical outcome in patients with severe-diffuse CAD 5. Degree of angina pectoris with Canadian Cardiovascular Society class II- IV angina Measured at week one, 1, 3, 6, 9 and 12 months	—

Countries

Taiwan

Outcome results

None listed

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