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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002518
Receipt No. R000003081
Scientific Title Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy
Date of disclosure of the study information 2009/10/01
Last modified on 2014/03/17

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Basic information
Public title Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy
Acronym AutoLogous human CArdiac-Derived stem cell to treat Ischemic cArdiomyopathy
(ALCADIA)
Scientific Title Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy
Scientific Title:Acronym AutoLogous human CArdiac-Derived stem cell to treat Ischemic cArdiomyopathy
(ALCADIA)
Region
Japan

Condition
Condition severe refractory heart failure with chronic ischemic cardiomyopathy
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac stem cells (hCSCs) with the controlled release of bFGF to severe refractory heart failure patients with chronic ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%<LVEF<35%)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
1. major adverse cardiac event (MACE)
(cardiovascular death, sustained ventricular arrhythmia, re-hospitalization for heart failure, new onset of acute cardiovascular syndrome, or cardiac tamponade which needs surgical repair)
2. serious adverse events without major adverse cardiac event
3. adverse event
Key secondary outcomes Efficacy
1. New York Heart Association (NYHA) class
2. Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method
3. regional wall motion score in infarct area by cardiac MRI
4. infarct volume evaluated by cardiac MRI with late Gd-enhancement

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1. Injection of autologous human cardiac stem cell.
Before proceeding with the trial, the isolated and cultured cardiac stem cell will need to reach a target of 5 x 10e5 cells/kg. Once the target number is achieved and quality is satisfactory during the procedure the stem cells will be injected intra-myocardially on the target site of the heart at 20 sites.
2. Implantation of gelatin hydrogel sheet incorporating bFGF.
All patients will receive an implantation of the controlled release of human recombinant basic fibroblast growth factor (bFGF) (200microgram) using a biodegradable gelatin hydrogel sheet.
3. CABG Surgery.
These procedure will be administered following completion of CABG surgery. The number of grafts will depend on the findings of the pre-operative angiogram.
4. Observation period; 1 year after surgery
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age: 20 to 80 years old
2) LV function: An ejection fraction (EF)>15%, and <35%
3) AHA/ACC stage: Stage D
4) NYHA: Class III or IV
5) An indication for CABG
A myocardial ischemia according to major coronary artery stenosis(>75%)
6) Viability in the infarct area:
as measured by cardiac delayed hyperenhancement magnetic resonance imaging (MRI)
1. Infarct area affecting>2 contiguous LV segments in a 18-segment model
2. The number of segments which transmural extent of hyperenhancment more than 51% is less than one.
Ex1. infarct area with or without bypass graft
Ex2. no correlation with graft number
Ex3. in case of multiple myocardial infarction, an
indication for larger in infarct volume
7) written informed consent
Key exclusion criteria 1) New onset of myocardial infarction or unstable angina within 28 days prior to study entry
2) Indication for surgical ventricular reconstruction or mitral valve repair *1
3) Contraindication for endomyocardial biopsy *2
4) Evidence for malignant disease within 3 years prior to study entry
5) Chronic hemodialysis
6) Liver Cirrhosis (ICGR 15>30%)
7) Uncontrollable diabetes mellitus (HbA1c>8.0)
8) Maximum diameter of Aortic aneurysm more than 5cm(including dissecting aneurysm)
9) Cardiogenic shock
10) Active infection (including cytomegalovirus infection)
11) Drug or alcoholic dependency
12) Positive for HIV antigen
13) Active bleeding state (gastric ulcer, cerebral bleeding, etc.)
14) Gelatin allergy *3
15) Chromosomal abnormality

*1 an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area
*2 contra-indication for endomyocardial biopsy
1 cardiogenic shock
2 end-stage or uncontrollable congestive heart
failure without continues infusion of
catecholamine
3 complete or mobitz type AV block
*3 The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-IgE
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsubara
Organization Kyoto Prefectural University School of Medicine
Division name The Department of Cardiovascular medicine
Zip code
Address 602-8566 Kajii-cho 465, hirokoji-agaru, kawaramachi-dori,kamikyoku, Kyoto,Japan
TEL 075-251-5111
Email matsubah@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Matsubara
Organization Kyoto Prefectural University School of Medicine
Division name The Department of Cardiovascular medicine
Zip code
Address 602-8566 Kajii-cho 465, hirokoji-agaru, kawaramachi-dori,kamikyoku, Kyoto,Japan
TEL 075-251-5111
Homepage URL http://www.f.kpu-m.ac.jp/k/med2/index.html
Email matsubah@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The National Cardiovascular Center

Translational Research Informatics Centre,
Foundation for Biomedical Research and Innovation,
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都府立医科大学付属病院
国立循環器病センター

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 01 Day

Related information
URL releasing protocol http://www.f.kpu-m.ac.jp/k/med2/index.html
Publication of results Partially published

Result
URL related to results and publications http://www.f.kpu-m.ac.jp/k/med2/index.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 21 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 17 Day
Last modified on
2014 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003081

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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