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AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA) (ALCADIA)

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ClinicalTrials.gov Identifier: NCT00981006
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
National Cerebral and Cardiovascular Center
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Asahikawa Medical College
Information provided by (Responsible Party):
Naofumi Takehara, Kyoto Prefectural University of Medicine

Tracking Information
First Submitted Date  ICMJE September 19, 2009
First Posted Date  ICMJE September 21, 2009
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2009)
The primary objective is to evaluate the safety of autologous cardiac-derived stem cells administered by intra-myocardial injection with the controlled release of bFGF in severe refractory heart failure patients with chronic ischemic cardiomyopathy. [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2009)
The secondary objective is to demonstrate the safety of autologous cardiac-derived stem cells administered by intra-myocardial injection with the controlled release of bFGF in severe refractory heart failure patients with chronic ischemic cardiomyopathy. [ Time Frame: 12month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)
Official Title  ICMJE 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
Brief Summary The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).
Detailed Description Autologous human stem or progenitor cells of different lineage have been subjected to clinical trials in the past to treat patients with ischemic cardiomyopathy. Although human stem or progenitor cells transplantation had functional benefits in the recovery in experimental myocardial infarction, the major barrier limiting its clinical application is the death of the most of the transplanted cells and poor cardiac differentiation in the host environment. Using the identical technique as clonally cell isolation from experimental animals, we generated human cardiac-derived stem cell (hCSC) enriched Es-marker genes with mesenchymal features. hCSCs included in cell populations accelerating proliferation in the presence of basic fibroblast growth factor (bFGF) on plastic plates are generated from human heart tissues through endomyocardial biopsy. Giving a patient their own hCSCs is an investigational procedure that has been approved by the committee of the Ministry of Health, Labour, and Welfare of Japan for this study. hCSCs have excellent potential to proliferate and regenerate to cardiomyocyte compared with other cells, e.g. myoblasts, bone marrow mononuclear cells and bone marrow stem cells, already evaluated in preliminary experiments on the repair of injured heart muscle. bFGF possesses properties to promote stem cell proliferation, and formation of sufficient microvascular network created by bFGF is critical for long-term survival of transplanted donor cells. This will be the first trial on the use of autologous hCSCs for the treatment of refractory heart failure with chronic ischemic cardiomyopathy. This trial is translational pilot study for looking into the safety and efficacy on the use of autologous hCSCs with the controlled release of bFGF using a gelatin hydrogel sheet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congestive Heart Failure
  • Ischemic Cardiomyopathy
  • Ventricular Dysfunction
Intervention  ICMJE Procedure: human cardiac stem cells
Single intramyocardial Injection of autologous hCSCs : 20 cites of infarcted myocardium Implantation of gelatin hydrogel sheet incorporating bFGF: 200 microgram. CABG surgery.
Other Names:
  • human cardiac stem cell (hCSC)
  • human recombinant basic fibroblast growth factor (bFGF)
  • coronary artery bypass grafting (CABG)
Study Arms  ICMJE Experimental: human cardiac stem cell therapy
single administration of 0.5 million cells/kg(patient body weight) of human cardiac stem cells and 200 microgram of bFGF at coronary artery bypass grafting (CABG)
Intervention: Procedure: human cardiac stem cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2009)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinical diagnosis of ischemic cardiomyopathy

    • Ischemic cardiomyopathy with old myocardial infarction due to coronary artery atherosclerotic disease.
  2. Age: 20 to 80 years old
  3. left ventricle (LV) dysfunction : An ejection fraction (EF)≧15%, and ≦35% assessed by echocardiography
  4. Refractory heart failure: American Heart Association (AHA)/American College of Cardiology (ACC)heart failure Stage D
  5. Heart failure symptom: New York Heart Association (NYHA) Class III or IV
  6. An indication for CABG:A myocardial ischemia according to major coronary artery stenosis (>75%)
  7. Viability in the infarct area as measured by cardiac delayed hyperenhancement magnetic resonance imaging (MRI)

    • Infarct area affecting >2 contiguous LV segments in a 18-segment model
    • The number of segments which transmural extent of hyperenhancement 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.
  8. written informed consent

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 5.5 cm.(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

      • cardiogenic shock
      • end-stage or uncontrollable congestive heart failure without continues infusion of catecholamine
      • complete or mobitz type atria-ventricular block
    • 3 The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-immunoglobulin E.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981006
Other Study ID Numbers  ICMJE TRICAD0910
TRICAD0806 ( Registry Identifier: TRI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naofumi Takehara, Kyoto Prefectural University of Medicine
Study Sponsor  ICMJE Naofumi Takehara
Collaborators  ICMJE
  • National Cerebral and Cardiovascular Center
  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
  • Asahikawa Medical College
Investigators  ICMJE
Principal Investigator: Hiroaki Matsubara, MD,PhD Kyoto Prefectural University School of Medicine
PRS Account Kyoto Prefectural University of Medicine
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP