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An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous ADSC Implantation by a Catheter Delivery System In Patients During the Subacute Recovery Phase of ST-Elevation MI
Sponsor study identifier
interventional
0
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2013
Actual (reported)September 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 5, 2017
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Improved cardiac function
Improvement is observed in cardiac function as assessed by echocardiographic LV function (EF)
3 and 6 months after intervention
Adverse Event
Duration of study
The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ageless Regenerative Institute LLC
Aventura, Florida, 33180, United States
Sharon McQuillan, MD
Ageless Regenerative Institute
0 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2013
First Posted
September 5, 2017
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 5, 2017
Record last verified: 2017-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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