Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050765
Status:
UNKNOWN
Last Update Posted:
2006-03-08
First Post:
2002-12-18
Brief Title:
Autologous Cultured Myoblasts BioWhittaker Transplanted Via Myocardial Injection
Sponsor:
Bioheart Inc
Organization:
Bioheart Inc
Study Overview
Official Title:
A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell Implantation in Patients With a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
MyoCell implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function Based on existing non-clinical studies and clinical reports implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation In a few investigational patients myoblast implantation can be and has been done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery The present study is being conducted to evaluate more fully the safety of MyoCell implantation via epicardial injection during CABG surgery and its effect on regional myocardial function
Detailed Description:
MyoCell mediated cellular cardiomyoplasty is a novel therapeutic approach to the management of progressive heart failure in patients who have damaged myocardial tissue resulting from a myocardial infarct MyoCell consists of patient autologous skeletal myoblasts which are expanded ex vivo and supplied as a cell suspension in a buffered salts solution for injection into the area of damaged akinetic myocardium with the goal of having the myoblasts populate the implant area and generate elastic contractile skeletal muscle-like tissue within the damaged myocardium Because the physiological goal is to replace inelastic fibrous myocardial scar tissue with skeletal muscle-like tissue originating from the cellular implants this therapeutic approach is termed cellular cardiomyoplasty or CCM
The purpose of this trial is to assess the safety of MyoCellexpanded autologous skeletal myoblasts using a dose escalation methodology following epicardial injection into myocardial scar tissue in patients who have experienced anterior lateral posterior or inferior wall myocardial infarction require coronary artery bypass graft CABG surgery and who have an implantable cardioverter defibrillator ICD in place ICD can be implanted during the CABG procedure or 3 to 4 days post CABG procedure Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell treatment
If a patient meets the baseline enrollment criteria a 5-10 gram skeletal muscle biopsy will be obtained for myoblast isolation and expansion in vitro at Biohearts designated facility for MyoCell production Biopsy will occur 3 - 4 weeks prior to the anticipated implantation of the MyoCell product At the time of the patients CABG surgery MyoCell will be injected into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile hypodermic syringe fitted with a 25 gauge needle
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each A report of the 1 month safety data from each cohort will be presented to the data safety monitoring board for permission to go to the next higher dosage In the first cohort of this dose escalation study 2 injections will be performed for the second cohort 6 injections and for the third cohort 18 injections depending on the size of the infarct scar so as to inject the entire myocardial infarct scar akinetic area
The purpose of this trial is to assess the safety of MyoCellexpanded autologous skeletal myoblasts using a dose escalation methodology following epicardial injection into myocardial scar tissue in patients who have experienced anterior lateral posterior or inferior wall myocardial infarction require coronary artery bypass graft CABG surgery and who have an implantable cardioverter defibrillator ICD in place ICD can be implanted during the CABG procedure or 3 to 4 days post CABG procedure Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell treatment
If a patient meets the baseline enrollment criteria a 5-10 gram skeletal muscle biopsy will be obtained for myoblast isolation and expansion in vitro at Biohearts designated facility for MyoCell production Biopsy will occur 3 - 4 weeks prior to the anticipated implantation of the MyoCell product At the time of the patients CABG surgery MyoCell will be injected into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile hypodermic syringe fitted with a 25 gauge needle
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each A report of the 1 month safety data from each cohort will be presented to the data safety monitoring board for permission to go to the next higher dosage In the first cohort of this dose escalation study 2 injections will be performed for the second cohort 6 injections and for the third cohort 18 injections depending on the size of the infarct scar so as to inject the entire myocardial infarct scar akinetic area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Version F | None | None | None |