Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT00684060

First received: May 22, 2008

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Results First Received: April 9, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Left Ventricular Dysfunction
Interventions:	Biological: Adult stem cells Biological: Placebo

Participant Flow

Show Participant Flow

Baseline Characteristics

Show Baseline Characteristics

Outcome Measures

Show All Outcome Measures

1. Primary:

Global Left Ventricular Function [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 1

2. Primary:

Regional Left Ventricular Function (Infarct Zone Wall Motion) [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 2

3. Primary:

Regional Left Ventricular Function (Border Zone Wall Motion) [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 3

4. Secondary:

Combined Endpoint [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 4

5. Secondary:

Left Ventricular Mass [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 5

6. Secondary:

End Diastolic Volume Index [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 6

7. Secondary:

End Systolic Volume Index [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 7

8. Secondary:

Infarct Volume [ Time Frame: Measured at Baseline and Month 6 ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lack of in-vivo testing of cell product. While there are several different approaches to measure myocardial strain (myocardial tagging, DENSE, etc.), these were not employed in this study due to the need for specialized expertise at each site.

Results Point of Contact:

Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
phone: 713-500-9518
e-mail: Lemmoye@msn.com

Publications of Results:

Traverse JH, Henry TD, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Forder JR, Byrne BJ, Hatzopoulos AK, Penn MS, Perin EC, Baran KW, Chambers J, Lambert C, Raveendran G, Simon DI, Vaughan DE, Simpson LM, Gee AP, Taylor DA, Cogle CR, Thomas JD, Silva GV, Jorgenson BC, Olson RE, Bowman S, Francescon J, Geither C, Handberg E, Smith DX, Baraniuk S, Piller LB, Loghin C, Aguilar D, Richman S, Zierold C, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moyé LA, Simari RD; Cardiovascular Cell Therapy ResearchNetwork. Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial. JAMA. 2011 Nov 16;306(19):2110-9. Epub 2011 Nov 14.

Other Publications:

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, Moyè 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.

Gee AP, Richman S, Durett A, McKenna D, Traverse J, Henry T, Fisk D, Pepine C, Bloom J, Willerson J, Prater K, Zhao D, Koç JR, Ellis S, Taylor D, Cogle C, Moyé 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.

Zierold C, Carlson MA, Obodo UC, Wise E, Piazza VA, Meeks MW, Vojvodic RW, Baraniuk S, Henry TD, Gee AP, Ellis SG, Moyé 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.

Responsible Party:	Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00684060 History of Changes
Other Study ID Numbers:	578, 1U01HL087318, 1 U01-HL-087318-01 (Project 2)
Study First Received:	May 22, 2008
Results First Received:	April 9, 2012
Last Updated:	January 18, 2013
Health Authority:	United States: Food and Drug Administration

To Top