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 interventio

Not Applicable

Completed

• Conditions: Chronic ischemic heart disease; Circulatory System; Chronic ischaemic heart disease, unspecified

• Registration Number: ISRCTN26002902
• Lead Sponsor: ational Science Council (Taiwan)

Brief Summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26154930 2020 results in https://pubmed.ncbi.nlm.nih.gov/32272750 (added 15/04/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32727585/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-11
• Study Completion: 2015-12-31
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The safety of intracoronary delivery of autologous CD34+ cells in patients with severely and diffusely atherosclerotic<br> 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).<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. The efficacy of autologous intracoronary CD34+ cell therapy on improving degree of Angina Pectoris.<br> 2. Quality of Life<br> 3. LV function<br> 4. Clinical Outcome in patients with severediffuse CAD<br><br> Methods and time points:<br> 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.<br> 2. Electrocardiogram: per day during hospitalization, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months.<br> 3. Echocardiography: 1 month, 3months, 6months.<br> 4. Tl-201: 6 months.<br> 5. Cardiac MRI: 6 months and 12 months.<br>