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History of Changes for Study: NCT00684060
Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
Latest version (submitted July 7, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 23, 2008 None (earliest Version on record)
2 June 13, 2008 Eligibility and Study Status
3 July 18, 2008 Recruitment Status, Study Status and Contacts/Locations
4 August 25, 2008 Contacts/Locations and Study Status
5 January 6, 2009 Contacts/Locations, Study Status and Eligibility
6 March 10, 2009 Contacts/Locations and Study Status
7 April 28, 2009 Study Status and Contacts/Locations
8 July 28, 2009 Study Status
9 January 19, 2010 Contacts/Locations, Study Status and Eligibility
10 June 15, 2010 Contacts/Locations, Study Status and Eligibility
11 December 21, 2010 Study Status
12 March 9, 2011 Recruitment Status, Study Status and Contacts/Locations
13 September 12, 2011 Study Status, Sponsor/Collaborators and Study Design
14 September 15, 2011 References and Study Status
15 April 9, 2012 Recruitment Status, Study Status, Outcome Measures, References and Results
16 May 7, 2012 Outcome Measures, Study Status
17 January 18, 2013 Sponsor/Collaborators, Study Identification and Study Status
18 July 7, 2015 Outcome Measures, Study Status, Baseline Characteristics
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Study NCT00684060
Submitted Date:  May 23, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: 578
Brief Title: Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
Official Title: A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction
Secondary IDs: 1 U01-HL-087318-01 (Project 2)
Open or close this module Study Status
Record Verification: May 2008
Overall Status: Not yet recruiting
Study Start: June 2008
Primary Completion: June 2011 [Anticipated]
Study Completion: December 2011 [Anticipated]
First Submitted: May 22, 2008
First Submitted that
Met QC Criteria:
May 23, 2008
First Posted: May 26, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 23, 2008
Last Update Posted: May 26, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).
Detailed Description:

Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a PCI can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. These specialized cells may have the ability to promote blood vessel growth, prevent cell death, and transform themselves into a number of tissues, including muscle. After an acute heart attack, a remodeling process is initiated in the heart in an attempt to compensate for damaged areas. Consequently, the condition of the heart muscle several weeks after a heart attack may differ considerably from the heart's condition during the acute setting. For some patients, delaying the delivery of the stem cells until 2 to 3 weeks after a heart attack may be better than initiating treatment during the acute phase. This study will evaluate the safety and effectiveness of placing adult stem cells into injured heart muscle 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a PCI.

Participation in this study will last 24 months. All participants will first undergo baseline assessments that will include a medical history, a physical exam, an electrocardiogram (ECG), blood draws, an echocardiogram, and a magnetic resonance imaging (MRI) test. Participants will then be assigned randomly to receive stem cells or placebo between 2 and 3 weeks after their heart attack. The morning of the stem cell or placebo infusion, participants will undergo a blood draw and a bone marrow aspiration procedure of the hip bone to collect the stem cells. Later the same day, either stem cells or placebo will be infused through a catheter and into the damaged area of the heart.

For the first 24 hours after the infusion, participants will be asked to wear a small ECG machine called a Holter monitor. Participants will also be asked to record their temperature twice a day for a month after the infusion. Participants will return for follow-up visits at Months 1, 3, 6, 12, and 24 and will repeat many of the baseline assessments.

Open or close this module Conditions
Conditions: Left Ventricular Dysfunction
Keywords: Acute Myocardial Infarction
Global Left Ventricular Ejection Fraction
Regional Left Ventricular Ejection Fraction
Left Ventricular Mass
Infarct Size
End Systolic Volume
End Diastolic Volume
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 87 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Biological: Adult stem cells
One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution
Other Names:
  • Adult autologous stem cells
  • Bone marrow mononucleated cells
Placebo Comparator: 2
Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Biological: Placebo
One time infusion of 30 ml of HSA (5%)
Other Names:
  • Human serum albumin
  • HSA
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Left ventricular ejection fraction (global and regional)
[ Time Frame: Measured at Month 6 ]

Secondary Outcome Measures:
1. Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure
[ Time Frame: Measured at Month 6 ]

2. Left ventricular mass
[ Time Frame: Measured at Month 6 ]

3. End diastolic volume
[ Time Frame: Measured at Month 6 ]

4. End systolic volume
[ Time Frame: Measured at Month 6 ]

5. Infarct size
[ Time Frame: Measured at Month 6 ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria:

  • Successful PCI in the left anterior descending (LAD) artery at least 2.5 mm in diameter within 2 to 3 weeks of onset of first acute anterior heart attack symptoms
  • No contraindications to undergoing cell therapy procedure within 2 to 3 weeks after acute heart attack and PCI
  • Hemodynamic stability, as defined as no requirement for intra-aortic balloon pump (IABP) or inotropic or blood pressure supporting medications
  • Ejection fraction after reperfusion with PCI less than or equal to 45%, as assessed by ECG
  • Woman of child bearing potential willing to use an active form of birth control

Exclusion criteria:

  • History of sustained ventricular arrhythmias not related to acute heart attack (evidenced by previous Holter monitoring and/or medication history for sustained ventricular arrhythmias in patient's medical chart)
  • Requires coronary artery bypass graft (CABG) or PCI due to the presence of residual coronary stenosis with greater than 70% luminal obstruction in the non-infarct related vessel (additional PCI of non-culprit vessels may be performed prior to enrollment)
  • History of any malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ
  • History of chronic anemia (hemoglobin less than 9.0 mg/dL)
  • History of thrombocytosis (platelets greater than 500,000)
  • Baseline platelet count (prior to revascularization) less than 120,000 or known history of thrombocytopenia
  • Known history of elevated international normalized ratio (INR) prothrombin time (PT) or partial thromboplastin time (PTT)
  • Life expectancy less than 1 year
  • History of untreated alcohol or drug abuse
  • Currently enrolled in another investigational drug or device trial
  • Previous CABG
  • Previous heart attack resulting in left ventricular dysfunction (left ventricular ejection fraction [LVEF] less than 55%)
  • History of stroke or transient ischemic attack within the 6 months before study entry
  • History of severe valvular heart disease (aortic valve area less than 1.0 cm2 or greater than 3+ mitral regurgitation)
  • Pregnant or breastfeeding
  • Known history of HIV, hepatitis B or C infection, or testing positive for tuberculosis
  • Active inflammatory or autoimmune disease and receiving chronic immunosuppressive therapy
  • Contraindications to MRI
  • Previous radiation to the pelvis with white blood cell count and platelet counts below hospital specific normal values
  • Hepatic dysfunction, as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN); or, total bilirubin greater than or equal to 2 times ULN with AST or ALT greater than or equal to two times ULN
  • Chronic renal insufficiency, as defined by a creatinine greater than or equal to 2.0 mg/dL or requires chronic dialysis
Open or close this module Contacts/Locations
Study Officials: Robert Simari, MD
Study Chair
Cardiovascular Cell Therapy Research Network
Locations: United States, Florida
University of Florida - Department of Medicine
Gainesville, Florida, United States, 32610
United States, Minnesota
Minneapolis Heart Institute Foundation (Abbott Northwestern Hospital)
Minneapolis, Minnesota, United States, 55407
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Click here for more information on this study at the Cardiovascular Cell Therapy Research Network (CCTRN)
Description: Click here for the National Heart, Lung, and Blood Institute
Available IPD/Information:

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