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Stem Cell Study for Patients With Heart Disease
This study has been completed.
First Received: April 26, 2004   Last Updated: January 23, 2008   History of Changes
Sponsored by: Losordo, Douglas, M.D.
Information provided by: Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier: NCT00081913
  Purpose

The purpose of this study is to determine if 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 and/or your ability to exercise.


Condition Intervention Phase
Chest Pain
Myocardial Ischemia
Heart Disease
Coronary Arterial Disease (CAD)
Angina
Genetic: Cell Therapy - Autologous CD34 Positive Cells
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia

Resource links provided by NLM:


Further study details as provided by Losordo, Douglas, M.D.:

Estimated Enrollment: 24
Study Start Date: January 2004
Study Completion Date: June 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

The goal of this study is to determine the safety of various doses of autologous (one's own) stem cells, delivered with a catheter into the regions of the heart with poor blood flow. Stem cells are primitive cells produced by bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating myocardial ischemia (the condition where areas in the heart are lacking enough oxygen and blood flow to keep the heart muscle working well).

This is a blinded, randomized study to compare a certain type of stem cell called CD34-positive versus a placebo agent (normal saline). You will have a 3:1 chance of receiving your CD34-positive stem cells versus the placebo agent (normal saline). You will not know whether you received the CD34-positive cells or the placebo agent (normal saline). If you are randomized to receive placebo (normal saline), you will undergo all of the pre-treatment phases of this study (including the stem cell mobilization phase and the apheresis procedure), but rather than receiving injections of CD34-positive cells, you will receive injections of the placebo agent (normal saline). There is some research evidence that suggests CD34-positive cells may help develop new blood vessels or improve blood flow when injected directly into the heart muscle.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with functional class (CCS) III or IV angina.
  • Subjects who have attempted "best" medical therapy without control of symptoms.
  • All subjects must have a recent coronary angiogram (within the last 3 months).
  • Clinical signs and symptoms of clinically significant ischemia on nuclear perfusion imaging.
  • Subjects must be able to complete a minimum of 1 minute but no more than 6 minutes of the Standard Bruce Protocol.
  • Subject experiences angina during the baseline exercise tolerance test.
  • Subjects must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study.
  • Normal renal function.
  • Normal liver function.
  • Normal blood count.

Angiographic Inclusions:

  • Total occlusion of an epicardial coronary artery.
  • Candidates at high risk for percutaneous coronary angioplasty of treatment zone(s) based upon clinical or anatomic considerations including but not limited to the following: diabetes, congestive heart failure (severe right heart failure, NYHA class III or IV), left main disease, pulmonary hypertension, severe proximal vessel tortuosity, severe bendpoint obstructions, diffuse disease (>2 cm in length), small vessel (<2 mm reference diameter), stenosis which are either diffuse (>2 cm in length) or distal, incessant restenosis lesions, unfavorable bifurcation stenosis, and degenerated or thrombosed saphenous vein grafts.

Exclusion Criteria:

  • Predominant congestive heart failure symptoms.
  • Patients who have been hospitalized with a primary diagnosis of CHF in the prior 6 months.
  • Patients who have had diuretics added to their medical regimen or an increase in diuretic dosage for signs or symptoms of CHF in the past 6 months.
  • Patients with a left ventricular ejection fraction of less than 25% as determined by transthoracic echocardiography.
  • Patients with physical findings consistent with ongoing uncontrolled CHF.
  • Myocardial infarction within 30 days of treatment.
  • Successful coronary revascularization procedures within 3 months of study enrollment.
  • Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
  • History of severe aortic stenosis or insufficiency; severe mitral stenosis; or severe mitral insufficiency.
  • Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
  • Subjects with PT, PTT or platelet counts greater than the upper limit of normal and those with a hematocrit <35%.
  • Subjects with uncontrolled hypertension.
  • Currently enrolled in another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period.
  • History of alcohol or drug abuse within 3 months of screening.
  • Joint or peripheral vascular disease that severely limits treadmill walking.
  • Chronic obstructive pulmonary disease that severely limits walking or FEV1.0<30% predicted.
  • Subjects who are pregnant or lactating.
  • Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study.
  • Subjects who test positive for HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications.
  • Subjects with a known hypersensitivity to E. coli-derived proteins.
  • Subjects with evidence (clinical, laboratory, or imaging) of cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081913

Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Losordo, Douglas, M.D.
  More Information

Additional Information:
No publications provided by Losordo, Douglas, M.D.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 00165
Study First Received: April 26, 2004
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00081913     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Losordo, Douglas, M.D.:
Apheresis
Cell Transfer
Chest Pain
Adult Stem Cell Therapy

Study placed in the following topic categories:
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Pain
Neovascularization, Pathologic
Ischemia
Chest Pain

Additional relevant MeSH terms:
Signs and Symptoms
Pathologic Processes
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Pain
Ischemia
Chest Pain

ClinicalTrials.gov processed this record on September 10, 2009