Completed

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

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What is being tested

Data Collection

Who is being recruted

Arterial Occlusive Diseases
+10

+ Arteriosclerosis
+ Cardiovascular Diseases
Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorLosordo, Douglas, M.D.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleInjection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia 
Principal SponsorLosordo, Douglas, M.D.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Neurologic Manifestations
Pain
Pathologic Processes
Vascular Diseases
Myocardial Ischemia
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).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Scripps ClinicLa Jolla, United StatesSee the location
Suspended
Caritas St. Elizabeth's Medical CenterBoston, United States
Suspended
Minneapolis Heart InstituteMinneapolis, United States
Completed3 Study Centers