Trial Outcomes & Findings for The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT) (NCT NCT00768066)

NCT ID: NCT00768066

Last Updated: 2015-12-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

65 participants

Primary outcome timeframe

one month post-catheterization

Results posted on

2015-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Study STARTED	22	22	21
Overall Study COMPLETED	19	19	21
Overall Study NOT COMPLETED	3	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Study Did not receive study product injection.	3	3	0

Baseline Characteristics

The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Total n=59 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 10.6 • n=5 Participants	61.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	60.6 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.6 years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants	55 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	21 participants n=5 Participants	59 participants n=4 Participants
Qualifying ejection fraction, %	35.8 percent STANDARD_DEVIATION 8.5 • n=5 Participants	36.3 percent STANDARD_DEVIATION 11.1 • n=7 Participants	33.0 percent STANDARD_DEVIATION 9.6 • n=5 Participants	34.9 percent STANDARD_DEVIATION 9.7 • n=4 Participants
History of Coronary Interventions Yes	19 participants n=5 Participants	18 participants n=7 Participants	20 participants n=5 Participants	57 participants n=4 Participants
History of Coronary Interventions No	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
History of Atrial/Ventricular Arrhythmia Yes	5 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	15 participants n=4 Participants
History of Atrial/Ventricular Arrhythmia No	14 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	44 participants n=4 Participants
History of Hyptertension Yes	12 participants n=5 Participants	12 participants n=7 Participants	16 participants n=5 Participants	40 participants n=4 Participants
History of Hyptertension No	7 participants n=5 Participants	7 participants n=7 Participants	5 participants n=5 Participants	19 participants n=4 Participants
History of Diabetes Yes	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants	14 participants n=4 Participants
History of Diabetes No	16 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	45 participants n=4 Participants
History of Congestive Heart Failure Yes	11 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	43 participants n=4 Participants
History of Congestive Heart Failure No	8 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	16 participants n=4 Participants
History of Smoking Yes	14 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants	40 participants n=4 Participants
History of Smoking No	5 participants n=5 Participants	9 participants n=7 Participants	5 participants n=5 Participants	19 participants n=4 Participants
New York Heart Association Class I	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
New York Heart Association Class II	12 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	32 participants n=4 Participants
New York Heart Association Class III	2 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	10 participants n=4 Participants
New York Heart Association Class Unknown	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants
Distance Walked in 6-Minutes	415.3 meters STANDARD_DEVIATION 67.9 • n=5 Participants	399.6 meters STANDARD_DEVIATION 95.0 • n=7 Participants	388.1 meters STANDARD_DEVIATION 58.4 • n=5 Participants	400.6 meters STANDARD_DEVIATION 74.4 • n=4 Participants
Peak VO2	18.8 mL/kg/min STANDARD_DEVIATION 3.8 • n=5 Participants	17.3 mL/kg/min STANDARD_DEVIATION 4.4 • n=7 Participants	14.6 mL/kg/min STANDARD_DEVIATION 5.6 • n=5 Participants	16.7 mL/kg/min STANDARD_DEVIATION 5.0 • n=4 Participants
Predicted FEV1	86.2 percent STANDARD_DEVIATION 15.7 • n=5 Participants	83.2 percent STANDARD_DEVIATION 23.2 • n=7 Participants	79.1 percent STANDARD_DEVIATION 20.1 • n=5 Participants	82.7 percent STANDARD_DEVIATION 19.8 • n=4 Participants
Device Automatic implanted cardioverter-defribillator	10 participants n=5 Participants	10 participants n=7 Participants	8 participants n=5 Participants	28 participants n=4 Participants
Device Biventricular Pacing	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants
Device None	8 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants	26 participants n=4 Participants
Imaging Modality MRI	13 participants n=5 Participants	13 participants n=7 Participants	15 participants n=5 Participants	41 participants n=4 Participants
Imaging Modality CT	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: one month post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation Yes	0 participants	0 participants	0 participants
Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation No	19 participants	19 participants	21 participants

SECONDARY outcome

Timeframe: Measured every 12 hours for the first 48 hours post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). Baseline	0.06 ng/mL Interval 0.02 to 0.1	0.06 ng/mL Interval 0.02 to 0.11	0.11 ng/mL Interval 0.0 to 0.25
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). 12-hours post-catheterization	0.82 ng/mL Interval 0.47 to 1.17	1.03 ng/mL Interval 0.06 to 1.99	0.98 ng/mL Interval 0.49 to 1.47
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). 24-hours post-catheterization	0.60 ng/mL Interval 0.29 to 0.91	0.45 ng/mL Interval 0.04 to 0.86	0.42 ng/mL Interval 0.18 to 0.67
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). 36-hours post-catheterization	0.39 ng/mL Interval 0.16 to 0.62	0.29 ng/mL Interval 0.01 to 0.57	0.31 ng/mL Interval 0.13 to 0.49
Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). 48-hours post-catheterization	0.31 ng/mL Interval 0.08 to 0.54	0.25 ng/mL Interval 0.01 to 0.49	0.22 ng/mL Interval 0.06 to 0.38

SECONDARY outcome

Timeframe: Measured every 12 hours for the first 48 hours post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). Baseline	1.61 ng/mL Interval 1.21 to 2.02	1.36 ng/mL Interval 0.8 to 1.91	1.64 ng/mL Interval 1.17 to 2.11
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). 12-hours post-catheterization	3.75 ng/mL Interval 2.7 to 4.8	2.98 ng/mL Interval 2.17 to 3.79	4.41 ng/mL Interval 2.31 to 6.51
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). 24-hours post-catheterization	2.19 ng/mL Interval 1.64 to 2.74	1.73 ng/mL Interval 1.23 to 2.24	2.85 ng/mL Interval 1.4 to 4.29
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). 36-hours post-catheterization	1.38 ng/mL Interval 1.11 to 1.66	1.28 ng/mL Interval 0.98 to 1.59	1.63 ng/mL Interval 1.03 to 2.23
Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). 48-hours post-catheterization	1.05 ng/mL Interval 0.84 to 1.27	1.03 ng/mL Interval 0.79 to 1.26	1.36 ng/mL Interval 0.81 to 1.91

SECONDARY outcome

Timeframe: 12 months post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. Yes	1 participants	0 participants	2 participants
Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. No	18 participants	19 participants	19 participants

SECONDARY outcome

Timeframe: 12 months post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Ectopic Tissue Formation. Yes	0 participants	0 participants	0 participants
Ectopic Tissue Formation. No	19 participants	19 participants	21 participants

SECONDARY outcome

Timeframe: 12-months post-catheterization

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Number of Deaths Yes	1 participants	0 participants	1 participants
Number of Deaths No	18 participants	19 participants	20 participants

SECONDARY outcome

Timeframe: 12 months post-catheterization

Data provided are with respect to the change from baseline at 12-months post-catheterization.

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=16 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=17 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=19 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).	32.6 meters Interval -4.6 to 69.7	16.9 meters Interval -14.2 to 48.0	6.3 meters Interval -31.4 to 44.0

SECONDARY outcome

Timeframe: 12 months post-catheterization

Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=16 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=17 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=15 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.	-6.3 units on a scale Interval -15.0 to 2.4	-8.2 units on a scale Interval -17.4 to 0.97	0.4 units on a scale Interval -9.5 to 10.3

SECONDARY outcome

Timeframe: 12 Months post-catheterization

Data provided are with respect to the change from baseline at 12-months post-catheterization.

Outcome measures

Outcome measures
Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=14 Participants Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=15 Participants Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=16 Participants Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.	-18.9 percent change Interval -30.4 to -7.4	-7.0 percent change Interval -15.7 to 1.7	-5.2 percent change Interval -16.8 to 6.5

Adverse Events

200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

200 Million Autologous Human Bone Marrow Cells (hBMCs)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Participants Will Receive a Placebo Injection of Phosphate-buf

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Adam Mendizabal, Biostatistician

The EMMES Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) n=19 participants at risk Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	200 Million Autologous Human Bone Marrow Cells (hBMCs) n=19 participants at risk Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.	Participants Will Receive a Placebo Injection of Phosphate-buf n=21 participants at risk Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Cardiac disorders Angina Pectoris	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Angina unstable	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	9.5% 2/21 • Number of events 2 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Atrial Fibrillation	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Atrioventricular block complete	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Cardiac arrest	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Intracardiac thrombus	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Cardiac disorders Ventricular tachycardia	10.5% 2/19 • Number of events 2 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Gastrointestinal disorders Colitis ulcerative	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
General disorders Chest discomfort	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
General disorders Chest Pain	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
General disorders Device electrical finding	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
General disorders Device malfunction	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
General disorders Fibrosis	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Infections and infestations Pneumonia	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	10.5% 2/19 • Number of events 2 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Nervous system disorders Cerebrovascular accident	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.3% 1/19 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/21 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Surgical and medical procedures Dyspnoea exertional	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.
Surgical and medical procedures Percutaneous coronary intervention	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	0.00% 0/19 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.	4.8% 1/21 • Number of events 1 • 30-days after transendocardial stem cell injection Adverse events are described by MedDRA preferred term.