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CompletedNCT00684021Updated Jun 30, 2015Results posted

Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)

A Phase 2 interventional study of Adult stem cells and Placebo in Left Ventricular Dysfunction, sponsored by The University of Texas Health Science Center, Houston. Completed at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-06-30.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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 percutaneous coronary intervention (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. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.

Read the detailed description

More than 1 million Americans suffer a heart attack each year, resulting in about a 38% mortality rate. 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. The permanent damage to the heart can lead to more severe problems, such as heart failure and irregular heartbeat, making the discovery of treatments to improve heart function after a heart attack important. 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. 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. 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 placing adult stem cells into injured heart muscle for improving heart function in people who have had a recent heart attack and a PCI. Additionally, this study will help determine the best time to insert stem cells after a heart attack.

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 either 3 or 7 days 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 following 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.

02

Conditions studied

  • 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
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 120 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients at least 21 years of age
  2. Patients with first acute MI with successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter within 24 hours of onset of symptoms.
  3. No contraindications to undergoing cell therapy procedure within three to seven days following AMI and PCI.
  4. Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.
  5. Ejection fraction following reperfusion with PCI \<=45% as assessed by echocardiography.
  6. Consent to protocol and agree to comply with all follow-up visits and studies.
  7. Women of child bearing potential willing to use an active form of birth control.

Exclusion criteria

Exclusion criteria

Patients will be excluded from the study if they meet any of the following conditions:

  1. History of sustained ventricular arrhythmias not related to their AMI (evidenced by previous holter monitoring and/or medication history for sustained ventricular arrhythmias in patient's medical chart).
  2. Require CABG or PCI due to the presence of residual coronary stenosis >70% luminal obstruction in the non-infarct related vessel (Additional PCI of non-culprit vessels may be performed prior to enrollment).
  3. History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.
  4. History of chronic anemia (hemoglobin (Hb) \<9.0 mg/dl).
  5. History of thrombocytosis (platelets >500k).
  6. History of thrombocytopenia in the absence of recent evidence that platelet counts are normal
  7. Known history of elevated INR (PT) or PTT.
  8. Life expectancy less than one year.
  9. History of untreated alcohol or drug abuse.
  10. Currently enrolled in another investigational drug or device trial
  11. Previous CABG.
  12. Previous MI resulting in LV dysfunction (LVEF \<55%)
  13. History of stroke or transient ischemic attack (TIA) within the past six months.
  14. History of severe valvular heart disease (aortic valve area \<1.0 cm2 or >3+ mitral regurgitation).
  15. Pregnancy or breast feeding
  16. Subjects with a known history of HIV, or has active hepatitis B,active hepatitis C, or active TB
  17. Patients with active inflammatory or autoimmune disease on chronic immuno-suppressive therapy.
  18. Contraindications to cMRI.
  19. Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.
  20. Women child bearing potential not willing to practice an active form of birth control.
  21. Chronic liver disease that might interfere with survival or treatment with cell therapy.
  22. Chronic renal insufficiency as defined by a creatinine ≥ 2.0 mg/dL or requires chronic dialysis.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    1

    Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).

    Biological: Adult stem cells

  • Active comparator
    2

    Participants will receive active adult stem cell infusion 7 days after PCI.

    Biological: Adult stem cells

  • Placebo comparator
    3

    Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 3 days after PCI.

    Biological: Placebo

  • Placebo comparator
    4

    Participants will receive placebo infusion (5% HSA) 7 days after PCI.

    Biological: Placebo

Interventions

  • BiologicalAdult stem cells

    One time infusion of approximately 150 million total nucleated cells (TNC) in 30 ml of 5% HSA/saline solution

    Also known as: Adult autologous stem cells, Bone marrow mononucleated cells

  • BiologicalPlacebo

    One time infusion of 30 ml of HSA (5%)

    Also known as: HSA

06

What researchers measure

Primary outcomes

  1. Global Left Ventricular Function

    Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.

    Time frame: Measured at Baseline and Month 6

  2. Regional Left Ventricular Function (Infarct Zone Wall Motion)

    One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.

    Time frame: Measured at Baseline and Month 6

  3. Regional Left Ventricular Function (Border Zone Wall Motion)

    Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.

    Time frame: Measured at Baseline and Month 6

Secondary outcomes

  1. Clincal and Safety Outcomes

    Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements

    Time frame: Measured from baseline to six months.

  2. Left Ventricular Mass

    Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.

    Time frame: Measured at Baseline and Month 6

  3. End Diastolic Volume Index

    Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.

    Time frame: Measured at Baseline and Month 6

  4. End Systolic Volume Index

    Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.

    Time frame: Measured at Baseline and Month 6

  5. Infarct Volume

    Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.

    Time frame: Measured at Baseline and Month 6

07

Results

Posted Apr 4, 2013
Limitations and caveats
The choice of Day 3 or Day 7 as randomization points while based on the literature were nevertheless somewhat arbitrary. cMR-baseed ejection fractions tended to be high.

Participant flow

Enrollment took place at five Network centers and their associated satellite facilities between July 2008 and November 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.

Participant flow — Overall Study
MilestoneDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Started43243617
Completed41223415
Not completed2222
Withdrew: Mri contraindicated1110
Withdrew: Mri not performed0112
Withdrew: Death1000

Outcome measures

PrimaryGlobal Left Ventricular Function

Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · percentage of ejection fraction
Global Left Ventricular Function
percentage of ejection fractionDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Global Left Ventricular Function3.5 ± 11.04.4 ± 10.62.8 ± 9.71.7 ± 8.2
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · t-test, 2 sided · p = 0.959 · Mean difference (final values): -0.1 · 95% CI -4.1 to 3.9Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
SecondaryClincal and Safety Outcomes

Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements

Time frame:
Measured from baseline to six months.
Reported as:
Number · events
Clincal and Safety Outcomes
eventsDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Clincal and Safety Outcomes10961
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Fisher Exact · p = 0.93 · Risk ratio (rr): 0.96 · 95% CI 0.42 to 2.23
SecondaryLeft Ventricular Mass

Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · g
Left Ventricular Mass
gDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Left Ventricular Mass-20.4 ± 22.8-13.2 ± 30.6-16.3 ± 16.7-20.7 ± 26.9
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Regression, Linear · p = 0.585 · Mean difference (net): -2.6 · 95% CI -12.2 to 6.9
SecondaryEnd Diastolic Volume Index

Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · mL/m2
End Diastolic Volume Index
mL/m2Day 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
End Diastolic Volume Index11.4 ± 18.511.7 ± 19.813.3 ± 19.59.7 ± 16.0
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Regression, Linear · p = 0.831 · Mean difference (net): 0.8 · 95% CI -6.6 to 8.2
SecondaryEnd Systolic Volume Index

Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · mL/m2
End Systolic Volume Index
mL/m2Day 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
End Systolic Volume Index4.1 ± 15.04.1 ± 16.56.2 ± 17.44.6 ± 12.8
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Regression, Linear · p = 0.817 · Mean difference (net): 0.7 · 95% CI -5.5 to 7.0
SecondaryInfarct Volume

Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · mL
Infarct Volume
mLDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Infarct Volume-9.7 ± 18.4-7.7 ± 23.4-13.6 ± 18.8-5.3 ± 29.3
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Regression, Linear · p = 0.272 · Mean difference (net): -4.7 · 95% CI -13.7 to 3.67
PrimaryRegional Left Ventricular Function (Infarct Zone Wall Motion)

One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · mm
Regional Left Ventricular Function (Infarct Zone Wall Motion)
mmDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Regional Left Ventricular Function (Infarct Zone Wall Motion)2.1 ± 5.92.4 ± 5.31.2 ± 4.92.8 ± 4.4
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · t-test, 2 sided · p = 0.409 · Mean difference (final values): -0.9 · 95% CI -3.0 to 1.2Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · Regression, Linear · p = 0.02 · Mean difference (net): 100 · 95% CI 15 to 1000
PrimaryRegional Left Ventricular Function (Border Zone Wall Motion)

Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.

Time frame:
Measured at Baseline and Month 6
Reported as:
Mean · mm
Regional Left Ventricular Function (Border Zone Wall Motion)
mmDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Regional Left Ventricular Function (Border Zone Wall Motion)3.5 ± 9.34.3 ± 8.74.2 ± 8.34.4 ± 7.2
Statistical analysis
  • Day 3 Stem Cell Arm vs Day 3 Placebo Arm vs Day 7 Stem Cell Arm vs Day 7 Placebo Arm · t-test, 2 sided · p = 0.777 · Mean difference (net): -0.5 · 95% CI -3.9 to 2.9Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.

Adverse events

Collected over Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Day 3 Stem Cell Arm—17/43 (39.5%)10/43 (23.3%)
Day 3 Placebo Arm—6/24 (25%)6/24 (25%)
Day 7 Stem Cell Arm—11/36 (30.6%)13/36 (36.1%)
Day 7 Placebo Arm—2/17 (11.8%)6/17 (35.3%)
Most frequent serious events
Most frequent serious events
EventDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Chest PainCardiac disorders8/432/241/360/17
New/Worsening ThrombusCardiac disorders1/432/245/361/17
Heart FailureCardiac disorders4/431/240/360/17
CardiomyopathyCardiac disorders1/431/241/361/17
AnginaCardiac disorders2/430/242/360/17
Coronary Artery DiseaseCardiac disorders1/430/242/360/17
Most frequent other events
Most frequent other events
EventDay 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo Arm
Groin bruising/bleedingCardiac disorders5/433/244/364/17
MalaiseGeneral disorders1/432/244/360/17
ThrombusCardiac disorders1/431/243/360/17
BronchitisRespiratory, thoracic and mediastinal disorders1/430/240/361/17
AnemiaBlood and lymphatic system disorders1/430/240/361/17
SyncopeNervous system disorders1/430/242/360/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Day 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo ArmTotal
Mean55.6 ± 10.857.0 ± 12.458.2 ± 11.357.0 ± 8.056.9 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Day 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo ArmTotal
Female535215
Male38213115105
Region of Enrollment
Region of Enrollment(participants)Day 3 Stem Cell ArmDay 3 Placebo ArmDay 7 Stem Cell ArmDay 7 Placebo ArmTotal
United States43243617120
08

Study locations

5 sites
  • University of Florida-Department of Medicine
    Gainesville, Florida 32610, United States
  • Minneapolis Heart Institute Foundation
    Minneapolis, Minnesota 55407, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Texas Heart Institute
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Traverse JH, Henry TD, Vaughan DE, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Piller LB, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moye' LA, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction. Am Heart J. 2009 Sep;158(3):356-63. doi: 10.1016/j.ahj.2009.06.009. Epub 2009 Jul 23. Erratum In: Am Heart J. 2009 Dec;158(6):1045. Vaughn, Douglas E [corrected to Vaughan, Douglas E]. PubMed 19699857 ↗
  • Gee AP, Richman S, Durett A, McKenna D, Traverse J, Henry T, Fisk D, Pepine C, Bloom J, Willerson J, Prater K, Zhao D, Koc JR, Ellis S, Taylor D, Cogle C, Moye L, Simari R, Skarlatos S. Multicenter cell processing for cardiovascular regenerative medicine applications: the Cardiovascular Cell Therapy Research Network (CCTRN) experience. Cytotherapy. 2010 Sep;12(5):684-91. doi: 10.3109/14653249.2010.487900. PubMed 20524773 ↗
  • Zierold C, Carlson MA, Obodo UC, Wise E, Piazza VA, Meeks MW, Vojvodic RW, Baraniuk S, Henry TD, Gee AP, Ellis SG, Moye LA, Pepine CJ, Cogle CR, Taylor DA. Developing mechanistic insights into cardiovascular cell therapy: Cardiovascular Cell Therapy Research Network Biorepository Core Laboratory rationale. Am Heart J. 2011 Dec;162(6):973-80. doi: 10.1016/j.ahj.2011.05.024. PubMed 22137069 ↗
  • Traverse JH, Henry TD, Pepine CJ, Willerson JT, Zhao DX, Ellis SG, Forder JR, Anderson RD, Hatzopoulos AK, Penn MS, Perin EC, Chambers J, Baran KW, Raveendran G, Lambert C, Lerman A, Simon DI, Vaughan DE, Lai D, Gee AP, Taylor DA, Cogle CR, Thomas JD, Olson RE, Bowman S, Francescon J, Geither C, Handberg E, Kappenman C, Westbrook L, Piller LB, Simpson LM, Baraniuk S, Loghin C, Aguilar D, Richman S, Zierold C, Spoon DB, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moye LA, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial. JAMA. 2012 Dec 12;308(22):2380-9. doi: 10.1001/jama.2012.28726. Erratum In: JAMA. 2013 Jan 23;309(4):343. JAMA. 2015 Jul 7;314(1):86. doi: 10.1001/jama.2015.6074. PubMed 23129008 ↗
  • Traverse JH, Henry TD, Pepine CJ, Willerson JT, Chugh A, Yang PC, Zhao DXM, Ellis SG, Forder JR, Perin EC, Penn MS, Hatzopoulos AK, Chambers JC, Baran KW, Raveendran G, Gee AP, Taylor DA, Moye L, Ebert RF, Simari RD. TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis. Circ Res. 2018 Feb 2;122(3):479-488. doi: 10.1161/CIRCRESAHA.117.311466. Epub 2017 Dec 5. PubMed 29208679 ↗
  • Schutt RC, Trachtenberg BH, Cooke JP, Traverse JH, Henry TD, Pepine CJ, Willerson JT, Perin EC, Ellis SG, Zhao DX, Bhatnagar A, Johnstone BH, Lai D, Resende M, Ebert RF, Wu JC, Sayre SL, Orozco A, Zierold C, Simari RD, Moye L, Cogle CR, Taylor DA; Cardiovascular Cell Therapy Research Network (CCTRN). Bone marrow characteristics associated with changes in infarct size after STEMI: a biorepository evaluation from the CCTRN TIME trial. Circ Res. 2015 Jan 2;116(1):99-107. doi: 10.1161/CIRCRESAHA.116.304710. Epub 2014 Nov 18. PubMed 25406300 ↗
  • Cogle CR, Wise E, Meacham AM, Zierold C, Traverse JH, Henry TD, Perin EC, Willerson JT, Ellis SG, Carlson M, Zhao DX, Bolli R, Cooke JP, Anwaruddin S, Bhatnagar A, da Graca Cabreira-Hansen M, Grant MB, Lai D, Moye L, Ebert RF, Olson RE, Sayre SL, Schulman IH, Bosse RC, Scott EW, Simari RD, Pepine CJ, Taylor DA; Cardiovascular Cell Therapy Research Network (CCTRN). Detailed analysis of bone marrow from patients with ischemic heart disease and left ventricular dysfunction: BM CD34, CD11b, and clonogenic capacity as biomarkers for clinical outcomes. Circ Res. 2014 Oct 24;115(10):867-74. doi: 10.1161/CIRCRESAHA.115.304353. Epub 2014 Aug 18. PubMed 25136078 ↗
  • Traverse JH, Henry TD, Pepine CJ, Willerson JT, Ellis SG. One-year follow-up of intracoronary stem cell delivery on left ventricular function following ST-elevation myocardial infarction. JAMA. 2014 Jan 15;311(3):301-2. doi: 10.1001/jama.2013.282674. No abstract available. Erratum In: JAMA. 2015 Jul 7;314(1):86. doi: 10.1001/jama.2015.6072. PubMed 24247415 ↗
  • Traverse JH, Henry TD, Vaughan DE, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Simpson LM, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Baraniuk S, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moye LA, Simari RD; Cardiovascular Cell Therapy Research Network. LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction. Tex Heart Inst J. 2010;37(4):412-20. PubMed 20844613 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00684021
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Dr Lemuel A Moye III (Professor - School of Public Health, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
May 26, 2008
Start date
Jul 2008
Primary completion
May 2012
Completion
Nov 2012
Results posted
Apr 4, 2013
Last update
Jun 30, 2015

Study contacts

Robert Simari, MD
study chair · Cardiovascular Cell Therapy Research Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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