![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Mytogen, Inc. |
---|---|
Information provided by: | Mytogen, Inc. |
ClinicalTrials.gov Identifier: | NCT00626314 |
The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts (grown from your own skeletal muscle), using a catheter device, directly into the damaged heart muscle for treatment of severe heart failure.
Condition | Intervention | Phase |
---|---|---|
Ischemic Cardiomyopathy |
Biological: myoblast Biological: sham |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Trial to Assess the Efficacy, Safety and Tolerability of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Myocardium, Using an Endomyocardial Delivery System |
Estimated Enrollment: | 165 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
myoblast
|
Biological: myoblast
autologous myoblast
|
2: Sham Comparator
sham injection procedure
|
Biological: sham
sham injection procedure
|
Given the limited treatment options available to patients with congestive heart failure, there is a need for alternative therapies. Autologous skeletal myoblast transplantation has been demonstrated in pre-clinical studies to be a safe and effective treatment of heart failure. Initial clinical studies have shown that autologous myoblasts can be delivered into infracted myocardium by both direct epicardial and endomyocardial injection. However, autologous skeletal myoblast transplantation via percutaneous endomyocardial injection has the potential to play a significant role in such congestive heart failure patients without the need for surgical risk and general anesthesia. Thus, a Phase 2 clinical trial is proposed in order to evaluate the effectiveness of autologous myoblast delivered by endomyocardial injection for the treatment congestive heart failure.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: JEROMY BROWN | 617-423-7999 ext 124 | JBrown@ccstrials.com |
United States, Arizona | |
Mercy Gilbert | |
GILBERT, Arizona, United States, 85297 |
Responsible Party: | MYTOGEN/ADVANCED CELL TECHNOLOGY ( JONATHAN DINSMORE, PHD/SENIOR VICE PRESIDENT, CLINICAL®ULATORY AFFAIRS ) |
Study ID Numbers: | EDAM06-5 |
Study First Received: | February 21, 2008 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00626314 |
Health Authority: | United States: Food and Drug Administration |
Heart Diseases Ischemia Cardiomyopathies |
Cardiovascular Diseases |