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Trial Outcomes & Findings for Feasibility Study of BMAC Enhanced CABG (NCT NCT01074099)

NCT ID: NCT01074099

Last Updated: 2016-01-18

Results Overview

A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Through 12 months post treatment

Results posted on

2016-01-18

Participant Flow

Participant milestones

Participant milestones
Measure
Control
CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection
BMAC Enhanced CABG
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Overall Study
STARTED
2
3
Overall Study
COMPLETED
2
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of BMAC Enhanced CABG

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=2 Participants
CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection
BMAC Enhanced CABG
n=3 Participants
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Total
n=5 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Region of Enrollment
United States
2 participants
n=99 Participants
3 participants
n=107 Participants
5 participants
n=206 Participants

PRIMARY outcome

Timeframe: Through 12 months post treatment

Population: Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.

A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: through 1 Year post tx

as measured by frequency and severity of adverse events

Outcome measures

Outcome measures
Measure
Control
n=2 Participants
CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection
BMAC Enhanced CABG
n=3 Participants
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Safety
0 participants
0 participants

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

BMAC Enhanced CABG

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Control
n=2 participants at risk
CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection
BMAC Enhanced CABG
n=3 participants at risk
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Cardiac disorders
sustained ventricular tachycardia
0.00%
0/2 • From time of treatment through 1 year / study termination
33.3%
1/3 • Number of events 1 • From time of treatment through 1 year / study termination

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Operations

Harvest Technologies

Phone: 508-732-7530

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60