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Trial Outcomes & Findings for Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure (NCT NCT00383630)

NCT ID: NCT00383630

Last Updated: 2019-04-17

Results Overview

This defines the functional status. Due to poor enrollment, data was not analyzed.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Measured 90 days post-intervention

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure
Study Subjects
Total number of subjects in the study; breakdown of the number per arm is not available.
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Subjects
n=1 Participants
Total number of subjects in the study; breakdown of the number per arm is not available.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Measured 90 days post-intervention

Population: The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.

This defines the functional status. Due to poor enrollment, data was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant

Population: The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.

Echocardiographic assessments of myocardial size and function by transthoracic echocardiography with the LVAD at full support, and as tolerated at 1, 5, 10 and 15 minutes following initiation of hand pumping. Due to poor enrollment, data was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant

Population: The study was terminated early due to logistical barriers to cell processing and poor enrollment and therefore sufficient data was not obtained for data analysis. Data analysis could not be performed.

6 Minute walk as tolerated at 15 minutes following initiation of hand pumping. Due to poor enrollment, results was not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Study Subjects

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

Serious adverse events

Serious adverse events
Measure
Study Subjects
n=1 participants at risk
Total number of subjects in the study; breakdown of the number per arm is not available.
General disorders
Shock
100.0%
1/1 • Number of events 1

Other adverse events

Other adverse events
Measure
Study Subjects
n=1 participants at risk
Total number of subjects in the study; breakdown of the number per arm is not available.
General disorders
Renal Dysfunction
100.0%
1/1 • Number of events 1
Blood and lymphatic system disorders
Blood Clot
100.0%
1/1 • Number of events 1

Additional Information

Yoshifumi Naka, MD, PhD

Columbia University

Phone: (212) 305-0828

Results disclosure agreements

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