Condition category
Circulatory System
Date applied
30/01/2012
Date assigned
17/02/2012
Last edited
30/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fan-Yen Lee

ORCID ID

Contact details

123
Ta Pei Road
Niao Sung Hsiang
Kaohsiung
83301
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

It is reasonable to seek both the safety, feasibility and potential effects on parameters of improving left ventricular (LV) ischemia and function and clinical outcome of intra-coronary infusion of CD34+ cells for patients who have angina pectoris that resulted in severely and diffusely atherosclerotic-obstructive coronary artery disease (CAD) with refractory to optimal medication are not the candidates for both Percutaneous Coronary Intervention (PCI) or coronary artery bypass graft (CABG), especially in the age of donor shortage.

Ethics approval

Institutional Review Committee on Human Research, Kaohsiung Chang Gung Memorial Hospital, 31 March 2011 ref: 99-3985A
Department of Health, Taiwan, 02 December 2011 ref: 1005056011

Study design

Prospective randomized double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic ischemic heart disease

Intervention

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 group will receive 3x107 CD34+ cells. Both groups will receive medical treatment as usual. Follow-up duration is one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

02/12/2011

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with age between 20-80 years-old
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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

02/12/2011

Recruitment end date

01/12/2014

Locations

Countries of recruitment

Taiwan

Trial participating centre

123, Ta Pei Road
Kaohsiung
83301
Taiwan

Sponsor information

Organisation

National Science Council (Taiwan)

Sponsor details

No.106
HoPing East Road
Sec. 2
Taipei
10622
Taiwan

Sponsor type

Government

Website

http://web1.nsc.gov.tw/

Funders

Funder type

Government

Funder name

National Science Council (Taiwan) ref: 100-2314-B-182A-077

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes