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Chest PainPhase 1/2NCT00221182

Stem Cell Study for Patients With Heart Disease

A Phase 1/2 study testing Autologous peripheral blood CD34 positive cell therapy in people with Chest Pain and Chronic Myocardial Ischemia, run by Foundation for Biomedical Research and Innovation at 3 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating… Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Autologous peripheral blood CD34 positive cell therapy
How many people
1 participants
Where
3 sitesJapan
Study dates
Sep 2005to Sep 2009
Phase
Phase 1/2
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

  • -Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study.
  • At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode.
  • Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography.
  • Patients with single vessel CAD and LVEF < 50%
  • Patients with multivessel CAD
  • Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy.
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  • Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
  • Age is between 20 and 80 (at time of consent).
  • Exercise tolerance time (ETT) duration ≥ 3 minutes and < 13 minutes on a modified Bruce protocol on 2 consecutive tests (> 24 hours but < 2 weeks apart), with the difference between the 2 exercise times within 25% of their mean (Patients should not be informed of exercise restrictions required for entry into the study).
  • Patients who can give informed consent themselves in writing.

Who cannot join

  • Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
  • Sustained ventricular tachycardia in a 24-hour ECG.
  • Chronic atrial fibrillation.
  • Less than 6 months since last episode of cerebral infarction.
  • Less than 6 months since last coronary angioplasty or less than 3 months since last bypass surgery.
  • Patients with unstable angina, with a treatment rating of 3 in the Braunwald system (refer to 5.4.), but a severity of III and a clinical rating of B or C.
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  • Presence of left ventricular thrombus by echocardiography
  • Patients with a malignant tumor*.
  • Patients with diabetic proliferating retinopathy** (new Fukuda classification BI to BV).
  • Patients with chronic rheumatoid arthritis.
  • Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • Patients currently suffering from or having a history of interstitial pneumonitis.
  • Patients for whom cranial MRA reveals cerebral aneurysm.
  • Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
  • Patients with cirrhosis of the liver.
  • Patients who cannot discontinue Warfarin.
  • Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  • Platelets less than 100,000/µL.
  • Hemoglobin less than 10 g/dL.
  • AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
  • Patients for whom it is impossible to perform both cardiac MRI and left ventriculography (LVG) (see 9.2.4 for cardiac MRI details and 9.2.9 for LVG details).
  • Patients with gate disturbance for reasons other than CAD (such as critical limb ischemia, sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult.
  • Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
  • Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Kobe Institute of Biomedical Research and Innovation

    Kobe, Hyogo-Pref., 650-0047

  • Kobe City General Hospital

    Kobe, Hyōgo

  • Okayama University School of Medicine

    Okayama, Okayama-ken, 700-8530

Other trials in Japan

About this study

Official title: Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Myocardial Ischemia

The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.

Read the detailed description

Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices.

Being tested
Autologous peripheral blood CD34 positive cell therapy
Keywords
Angina, Heart diseases, Pain, Vascular diseases
Medical subject headings
Chest Pain, Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Heart Diseases, Pain, Vascular Diseases

What participants receive

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

  • Autologous peripheral blood CD34 positive cell therapyGenetic

What is being measured

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

  1. Efficacy: Severity of myocardial perfusion abnormality by sestamibi SPECT stress myocardial scintigraphy

  2. Safety: Severe adverse events within 4 weeks after cell therapy

Secondary outcomes (4)

  1. CCSAS (Canada Cardiovascular Society Anginal Score)

  2. NYHA (New York Heart Association) classification

  3. Exercise tolerance by treadmill

  4. Left ventricular function by cardiac MRI

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionSep 2009
  4. Study completionSep 2009

Why it stopped: slow recruitment of the study subjects

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221182
Sponsor's protocol ID
BRI CAD 04-01
Status last verified
Jun 2011
First submitted
13 Sep 2005
Last updated
22 Jun 2011
Results posted
No

Publications

  • Asahara T, Kawamoto A. Endothelial progenitor cells for postnatal vasculogenesis. Am J Physiol Cell Physiol. 2004 Sep;287(3):C572-9. doi: 10.1152/ajpcell.00330.2003.

    PubMed 15308462

  • Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. doi: 10.1161/01.cir.0000046450.89986.50.

    PubMed 12551872

  • Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.

    PubMed 11156872

  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PubMed 9020076

  • Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. doi: 10.1038/7434.

    PubMed 10202935

  • Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.

    PubMed 10725398

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous peripheral blood CD34 positive cell therapy in people with Chest Pain and Chronic Myocardial Ischemia, run by Foundation for Biomedical Research and Innovation at 3 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 10 inclusion and 25 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: stopped early, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: slow recruitment of the study subjects). Results are not available in the source record.

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?

Efficacy: Severity of myocardial perfusion abnormality by sestamibi SPECT stress myocardial scintigraphy. The study lists 2 primary outcomes in all. 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 NCT00221182, which also lists 6 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 22 Jun 2011.

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Stem Cell Study for Patients With Heart Disease | AzTrials