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Chest PainPhase 1NCT00081913

Stem Cell Study for Patients With Heart Disease

A Phase 1 study testing Cell Therapy - Autologous CD34 Positive Cells in people with Chest Pain and Myocardial Ischemia, run by Losordo, Douglas, M.D. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chest Pain, Myocardial Ischemia, Heart Disease
What is being tested?
Cell Therapy - Autologous CD34 Positive Cells
How many people
24 participants
Where
3 sitesUnited States
Study dates
Jan 2004to Jun 2006
Phase
Phase 1
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Scripps Clinic

    La Jolla, California, 92037

  • Minneapolis Heart Institute

    Minneapolis, Minnesota

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cell Therapy - Autologous CD34 Positive Cells
Keywords
Apheresis, Cell Transfer, Chest Pain, Adult Stem Cell Therapy
Medical subject headings
Chest Pain, Myocardial Ischemia, Heart Diseases, Angina Pectoris

What participants receive

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

  • Cell Therapy - Autologous CD34 Positive CellsGenetic

Timeline

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

  1. First posted28 Apr 2004 (estimated)
  2. Study startJan 2004
  3. Primary completionMar 2006
  4. Study completionJun 2006

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
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
24 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081913
Sponsor's protocol ID
00165
Status last verified
Jan 2008
First submitted
26 Apr 2004
Last updated
29 Jan 2008
Results posted
No

Publications

  • Losordo DW, Schatz RA, White CJ, Udelson JE, Veereshwarayya V, Durgin M, Poh KK, Weinstein R, Kearney M, Chaudhry M, Burg A, Eaton L, Heyd L, Thorne T, Shturman L, Hoffmeister P, Story K, Zak V, Dowling D, Traverse JH, Olson RE, Flanagan J, Sodano D, Murayama T, Kawamoto A, Kusano KF, Wollins J, Welt F, Shah P, Soukas P, Asahara T, Henry TD. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation. 2007 Jun 26;115(25):3165-72. doi: 10.1161/CIRCULATIONAHA.106.687376. Epub 2007 Jun 11.

    PubMed 17562958

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cell Therapy - Autologous CD34 Positive Cells in people with Chest Pain and Myocardial Ischemia, run by Losordo, Douglas, M.D. at 3 sites in United States.

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 13 inclusion and 21 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: finished, as of the sponsor's last update on 29 Jan 2008. 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 United States. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081913, which also lists 1 linked publication.

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 29 Jan 2008.

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