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Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia

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Trial Conditions
  • Chest Pain
  • Myocardial Ischemia
  • Heart Disease
  • Coronary Arterial Disease (CAD)
  • Angina
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
21 and older

Gender:
Both

Eligibility

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).

Gender: Both
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Genetic
  • Cell Therapy - Autologous CD34 Positive Cells
Other Information

Sponsor: Losordo, Douglas, M.D.
Phase: Phase 1
Trial ID: NCT00081913
Volunteers:  Not Accepting Healthy Volunteers

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