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Table 1 Summary of efficacy - all treated patients (IMPACT-DCM)

From: The Aastrom experience

  

IDCM

  

NIDCM

  

Ixmyelocel-T

Control

Ixmyelocel-T

Control

Percent of patients with MACE adverse events

     

Enrolled patients

 

12

7

12

8

All MACE events (n (%))

 

6 (50.0)

5 (71.4)

5 (41.7)

2 (25.0)

Total MACE events

 

8

8

8

3

Event on day 0/injection (n (%))

 

2 (16.7)

0

1 (8.3)

0

Total MACE events day 0/injection

 

2

0

1

0

Event on days 1 to 365 (n (%))

 

3 (25.0)

4 (57.1)

4 (33.3)

1 (12.5)

Total MACE events days 1 to 365

 

5

7

7

1

Event on day 366+ (n (%))

 

1 (8.3)

1 (14.3)

0

1 (12.5)

Total MACE events day 366+

 

1

1

0

2

Number of patients with improvements from baseline in efficacy/total patients in group

 

12 months

9/10

1/3

7/9

2/3

Increase in six minute walk test

12 months

6/10

0/3

8/9

3/3

Increase in echocardiogram ejection fraction

12 months

3/7

0/2

4/7

1/2

  1. IDCM, ischemic dilated cardiomyopathy; MACE, major adverse cardiac event; NIDCM, non-ischemic dilated cardiomyopathy; NYHA, New York Heart Association.