|
Stem Cell Study for Patients with Heart Disease Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Stem Cell Study for Patients with Heart Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Stem Cell Study for Patients with Heart Disease Clinical research trials and Stem Cell Study for Patients with Heart Disease healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Stem Cell Study for Patients with Heart Disease. Stem Cell Study for Patients with Heart Disease Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Stem Cell Study for Patients with Heart Disease clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Stem Cell Study for Patients with Heart Disease condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Stem Cell Study for Patients with Heart Disease  Stem Cell Study for Patients with Heart Disease
Stem Cell Study for Patients with Heart Disease
For Condition: Chest Pain,Coronary Arterial Disease (CAD),Angina,Myocardial Ischemia,Heart Disease
Status: Recruiting
Sponsor(s): Losordo, Douglas, M.D. , Caritas St. Elizabeth's Medical Center of Boston
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 24
Location and Contact Information:
Minneapolis Heart Institute *Not yet recruiting*
Minneapolis, Minnesota,
United States
Not yet recruiting
Scripps Clinic *Not yet recruiting*
La Jolla, California, 92037
United States
Not yet recruiting
Caritas St. Elizabeth's Medical Center *Recruiting*
Boston, Massachusetts, 02135
United States
Recruiting Daniela Grasso 617-779-6394
Additional Information:
Study ID Numbers: 00165;
Study Start Date: January 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081913
Other Chest Pain Studies:
1. Deferoxamine for the Treatment of Hemochromatosis
2. Evaluation of Patients with Known or Suspected Heart Disease
3. Outpatient Evaluation of Patients with Known or Suspected Heart Disease
4. Evaluation of Patients with Heart Disease Not Eligible for Research Protocols
5. Cardiac Vulnerability in Potentially Susceptible Patients
Related Studies:
Other Chest Pain Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Stem Cell Study for Patients with Heart Disease
|
|
|
|
|
|
|
|
