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

Not Applicable

Completed

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

• Registration Number: ISRCTN72853206
• Lead Sponsor: ational Science Council (Taiwan)

Brief Summary

2015 results in https://pubmed.ncbi.nlm.nih.gov/26154930/ (added 17/12/2020) 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: 2012-02-17
• Study Completion: 2014-12-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

1. Age <20 years or > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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.<br>

Secondary Outcome Measures

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