Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054678
Status:
UNKNOWN
Last Update Posted:
2007-10-15
First Post:
2003-02-06
Brief Title:
MYOHEART Myogenesis Heart Efficiency and Regeneration Trial
Sponsor:
Bioheart Inc
Organization:
Bioheart Inc
Study Overview
Official Title:
A Phase I Open-Label Non-Randomized Dose Escalation Multi Center Study to Assess the Safety and Cardiovascular Effects of Autologous Skeletal Myoblast Implantation by a Transendocardial Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarctions With Previous Placement of ICD
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The MyoCell implantation using the MyoCath delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure Based on pre-clinical studies implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same effects In principal myoblast implantation by catheter delivery may offer the same therapeutic benefit The present clinical study is to be conducted primarily to evaluate the safety of MyoCell implantation using the MyoCath delivery system and secondarily to evaluate the effect on regional myocardial function post treatment
Detailed Description:
A very promising approach to reversal or stabilization of the post-infarct remodeling process is the direct injection of regenerative cells into the myocardial infarct scar Such cell-based therapy for cardiac repair is called cellular cardiomyoplasty
The MyoCell implantation using the MyoCath delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure MyoCath is Biohearts proprietary catheter delivery system being developed by Bioheart to facilitate MyoCell delivery into the myocardium via the retrograde catheterization of the left ventricular cavity Based on pre-clinical studies implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG or via the endoventricular approach may lead to the same effects In principle myoblast implantation by catheter delivery may offer the same therapeutic benefit
The present clinical study is to be conducted primarily to
1 Assess the safety and effect on myocardial function of MyoCell autologous skeletal myoblast using a dose escalation methodology following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarctions and have had an implantable cardioverter defibrillator ICD previously implanted Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell treatment
2 To assess the safety and feasibility of using the transendocardial injection catheter MyoCath as a system for delivering MyoCell into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarctions and have an implantable cardioverter defibrillator ICD previously implanted Catheter performance will be assessed at the time of the implantation using clinical evaluation questionnaires Safety endpoints will be the evaluation of the nature and frequency of Adverse Events from the time of implantation to the Day 14 follow-up visit
If a patient meets the baseline enrollment criteria approximately 5-10 grams of skeletal muscle is obtained from the subjects leg muscle for myoblast isolation and expansion in vitro MyoCell at a specified off site cGMP culture laboratory The expanded myoblast cells MyoCell will be implanted into the akinetic myocardial scar in the region of a previous infarct utilizing Biohearts MyoCath transendocardial delivery catheter system The MyoCath endoventricular device is expected to deliver the MyoCell autologous skeletal myoblast cells into the scarred myocardial region by steering a catheter which contains a retractable hypodermic needle to the targeted sites for implantation
This will be a dose escalation study with 4 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 for the third cohort 18 injections and for the fourth cohort 27 injections depending on the size of the infarct scar so as to inject the entire myocardial infarct scar akinetic area
The entire study is expected to be completed during the first half of 2007 including completed enrollment as well as 12-month follow-up of the last subject
The MyoCell implantation using the MyoCath delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure MyoCath is Biohearts proprietary catheter delivery system being developed by Bioheart to facilitate MyoCell delivery into the myocardium via the retrograde catheterization of the left ventricular cavity Based on pre-clinical studies implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG or via the endoventricular approach may lead to the same effects In principle myoblast implantation by catheter delivery may offer the same therapeutic benefit
The present clinical study is to be conducted primarily to
1 Assess the safety and effect on myocardial function of MyoCell autologous skeletal myoblast using a dose escalation methodology following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarctions and have had an implantable cardioverter defibrillator ICD previously implanted Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell treatment
2 To assess the safety and feasibility of using the transendocardial injection catheter MyoCath as a system for delivering MyoCell into myocardial scar tissue of subjects with congestive heart failure who have experienced previous myocardial infarctions and have an implantable cardioverter defibrillator ICD previously implanted Catheter performance will be assessed at the time of the implantation using clinical evaluation questionnaires Safety endpoints will be the evaluation of the nature and frequency of Adverse Events from the time of implantation to the Day 14 follow-up visit
If a patient meets the baseline enrollment criteria approximately 5-10 grams of skeletal muscle is obtained from the subjects leg muscle for myoblast isolation and expansion in vitro MyoCell at a specified off site cGMP culture laboratory The expanded myoblast cells MyoCell will be implanted into the akinetic myocardial scar in the region of a previous infarct utilizing Biohearts MyoCath transendocardial delivery catheter system The MyoCath endoventricular device is expected to deliver the MyoCell autologous skeletal myoblast cells into the scarred myocardial region by steering a catheter which contains a retractable hypodermic needle to the targeted sites for implantation
This will be a dose escalation study with 4 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 for the third cohort 18 injections and for the fourth cohort 27 injections depending on the size of the infarct scar so as to inject the entire myocardial infarct scar akinetic area
The entire study is expected to be completed during the first half of 2007 including completed enrollment as well as 12-month follow-up of the last subject
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 G | None | None | None |