MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)
Recruitment status was: Active, not recruiting
|First Received Date ICMJE||February 6, 2003|
|Last Updated Date||October 11, 2007|
|Start Date ICMJE||February 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To assess the safety of Myocel following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous MI.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00054678 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)|
|Official Title ICMJE||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 Infarction(s) With Previous Placement of ICD|
|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.|
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 Bioheart's 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:
If a patient meets the baseline enrollment criteria, approximately 5-10 grams of skeletal muscle is obtained from the subject's 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 Bioheart's 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 Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients who meet all of the following inclusion criteria and none of the exclusion criteria will be enrolled in this clinical study.
|Ages||30 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00054678|
|Other Study ID Numbers ICMJE||BMI-US-01-002, Version G|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Bioheart, Inc.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Bioheart, Inc.|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP