NCT00981006

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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2010

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.9 years

First QC Date

September 19, 2009

Last Update Submit

March 31, 2015

Conditions

Congestive Heart FailureIschemic CardiomyopathyVentricular Dysfunction

Keywords

ischemic cardiomyopathy (ICM)

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 month

Secondary Outcomes (1)

  • 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.

    12month

Study Arms (1)

human cardiac stem cell therapy

EXPERIMENTAL

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)

Procedure: human cardiac stem cells

Interventions

human cardiac stem cellsPROCEDURE

Single intramyocardial Injection of autologous hCSCs : 20 cites of infarcted myocardium Implantation of gelatin hydrogel sheet incorporating bFGF: 200 microgram. CABG surgery.

Also known as: human cardiac stem cell (hCSC), human recombinant basic fibroblast growth factor (bFGF), coronary artery bypass grafting (CABG)
human cardiac stem cell therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of ischemic cardiomyopathy
  • Ischemic cardiomyopathy with old myocardial infarction due to coronary artery atherosclerotic disease.
  • Age: 20 to 80 years old
  • left ventricle (LV) dysfunction : An ejection fraction (EF)≧15%, and ≦35% assessed by echocardiography
  • Refractory heart failure: American Heart Association (AHA)/American College of Cardiology (ACC)heart failure Stage D
  • Heart failure symptom: New York Heart Association (NYHA) Class III or IV
  • An indication for CABG:A myocardial ischemia according to major coronary artery stenosis (\>75%)
  • 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.
  • written informed consent

You may not qualify if:

  • New onset of myocardial infarction or unstable angina within 28 days prior to study entry
  • Indication for surgical ventricular reconstruction or mitral valve repair \*1
  • Contraindication for endomyocardial biopsy \*2
  • Evidence for malignant disease within 3 years prior to study entry
  • Chronic hemodialysis
  • Liver Cirrhosis (ICGR 15 \>30%)
  • Uncontrollable diabetes mellitus (HbA1c\>8.0)
  • Maximum diameter of Aortic aneurysm more than 5.5 cm.(including dissecting aneurysm)
  • Cardiogenic shock
  • Active infection (including cytomegalovirus infection)
  • Drug or alcoholic dependency
  • Positive for HIV antigen
  • Active bleeding state (gastric ulcer, cerebral bleeding, etc.)
  • Gelatin allergy \*3
  • Chromosomal abnormality
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kyoto Prefectural University School of Medicine

Kyoto, Kajii-cho 465, Hirokoji-agaru, Kawaramachi-dori,kamikyoku, 602-8566, Japan

Location

National Cardiovascular Center

Osaka, Japan

Location

Related Publications (4)

  • Takehara N, Tsutsumi Y, Tateishi K, Ogata T, Tanaka H, Ueyama T, Takahashi T, Takamatsu T, Fukushima M, Komeda M, Yamagishi M, Yaku H, Tabata Y, Matsubara H, Oh H. Controlled delivery of basic fibroblast growth factor promotes human cardiosphere-derived cell engraftment to enhance cardiac repair for chronic myocardial infarction. J Am Coll Cardiol. 2008 Dec 2;52(23):1858-1865. doi: 10.1016/j.jacc.2008.06.052.

    PMID: 19038683BACKGROUND

  • Tateishi K, Ashihara E, Takehara N, Nomura T, Honsho S, Nakagami T, Morikawa S, Takahashi T, Ueyama T, Matsubara H, Oh H. Clonally amplified cardiac stem cells are regulated by Sca-1 signaling for efficient cardiovascular regeneration. J Cell Sci. 2007 May 15;120(Pt 10):1791-800. doi: 10.1242/jcs.006122.

    PMID: 17502484BACKGROUND

  • Tateishi K, Ashihara E, Honsho S, Takehara N, Nomura T, Takahashi T, Ueyama T, Yamagishi M, Yaku H, Matsubara H, Oh H. Human cardiac stem cells exhibit mesenchymal features and are maintained through Akt/GSK-3beta signaling. Biochem Biophys Res Commun. 2007 Jan 19;352(3):635-41. doi: 10.1016/j.bbrc.2006.11.096. Epub 2006 Nov 27.

    PMID: 17150190BACKGROUND

  • Chimenti I, Gaetani R, Forte E, Angelini F, De Falco E, Zoccai GB, Messina E, Frati G, Giacomello A. Serum and supplement optimization for EU GMP-compliance in cardiospheres cell culture. J Cell Mol Med. 2014 Apr;18(4):624-34. doi: 10.1111/jcmm.12210. Epub 2014 Jan 20.

    PMID: 24444305DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureVentricular Dysfunction

Interventions

KCB-1 protein, recombinantCoronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Hiroaki Matsubara, MD,PhD

    Kyoto Prefectural University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2009

First Posted

September 21, 2009

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

JP(2)