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Congestive Heart FailurePhase 1ALCADIANCT00981006

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

A Phase 1 study testing human cardiac stem cells in people with Congestive Heart Failure and Ischemic Cardiomyopathy, run by Naofumi Takehara at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
human cardiac stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesJapan
Study dates
Apr 2010to Mar 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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%)
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  • 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
  • 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.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Kyoto Prefectural University School of Medicine

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

  • National Cardiovascular Center

    Osaka

Other trials in Japan

About this study

Official 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

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%).

Read the 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.

Being tested
human cardiac stem cells
Keywords
ischemic cardiomyopathy (ICM)
Medical subject headings
Heart Failure, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human cardiac stem cellsProcedure or surgery

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

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

Study groups in NCT00981006
Study groupRoleWhat they receive
human cardiac stem cell therapyExperimentalsingle 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)
Receives: Procedure: human cardiac stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 month

Secondary outcomes (1)

  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.

    Measured: 12month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00981006
Sponsor's protocol ID
TRICAD0910
Other IDs
TRICAD0806
Acronym
ALCADIA
Status last verified
Mar 2015
First submitted
19 Sep 2009
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19038683

  • 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.

    PubMed 17502484

  • 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.

    PubMed 17150190

  • 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.

    PubMed 24444305

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing human cardiac stem cells in people with Congestive Heart Failure and Ischemic Cardiomyopathy, run by Naofumi Takehara at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00981006, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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