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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment took place at five Network centers and their associated satellite facilities between July 8, 2008 and February 28, 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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Stem Cell Arm	Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm	Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Participant Flow:   Overall Study

	Stem Cell Arm	Placebo Arm
STARTED	58	29
COMPLETED	55	26
NOT COMPLETED	3	3
Lost to Follow-up	1	0
New stenosis identified	1	0
Unable to collect MRI	1	2
Death	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Stem Cell Arm	Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm	Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Total	Total of all reporting groups

Baseline Measures

	Stem Cell Arm	Placebo Arm	Total
Overall Participants Analyzed  [Units: Participants]	58	29	87
Age  [Units: Years] Mean (Standard Deviation)	57.6  (11)	54.6  (11)	57  (11)
Gender  [Units: Participants]
Female	12	3	15
Male	46	26	72
Region of Enrollment  [Units: Participants]
United States	58	29	87

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Secondary:

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

5.  Secondary:

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

6.  Secondary:

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

7.  Secondary:

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

8.  Secondary:

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

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.