U.S. Trials
TITLE |
#OF PATIENTS |
SITES |
OBJECTIVE |
STATUES |
MARVEL (Phase II/III Clinical Trial) |
MARVEL Part 1: 20 Patients (completed) MARVEL Part 2: 133 Patients |
Up to 35 sites in the United States |
Designed to be a double blind, randomized, placebo controlled multi-center trial to evaluate the safety and efficacy of MyoCell® delivered via MyoStar® |
MyoCell® implantation procedure completed on first patient in October 2007. MARVEL part 1 data on the first 20 patients analyzed and presented at the Heart Failure Society of America (HFSA) Meeting in 2009. Data displayed overall positive clinical result |
ANGEL Phase I Trial |
5 Patients |
Hospital Angeles |
Phase I study to assess safety and feasibility of AdipoCell™ |
Enrollment Complete |
MYOHEART (Phase I Clinical Trial) |
20 |
Five sites in the United States |
Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. |
Trial commenced in 2003; treatment of all 20 patients completed in October 2006; final twelve-month data presented in January 2008. |
REGEN (Phase I Clinical Trial) |
15 |
3 Sites in US |
Designed to test the safety and effectiveness of a composition of muscle stem cells that have been gene-modified to induce a greater than usual release of the SDF-1 protein |
Approval received in July 2009 from the FDA to move forward with the trail. |
.
European Trials
European Trials
TITLE |
#OF PATIENTS |
SITES |
OBJECTIVE |
STATUES |
2002 Trial |
3 |
o |
One site in the Netherlands |
Trial commenced in 2002. Discontinued upon Transvascular's acquisition by Medtronic |
Netherlands Phase I Clinical Trial |
3 |
One site in the Netherlands |
Pilot study to assess safety and feasibility of MyoCell®. |
Trail commenced in 2001; six-month follow-up completed in October 2003. |
Phase I/II Clinical Trial |
15 |
Three sites in the Netherlands, Germany and Italy. |
s |
Trial commenced in 2002; twelve-month follow-up completed in June 2004. |
SEISMIC (Phase II Clinical Trial) |
40, including 14 controls. |
Twelve sites in the Netherlands, Germany, Belgium, Spain, Poland, and the United Kingdom. |
Phase II European study to assess the safety and efficacy of MyoCell® therapy delivered via MyoCath® catheter. |
Trail commenced in November 2005; treatment of all patients completed in July 2007; final results presented in April 2008. |
