SEISMIC (Phase II)

Phase II European study to assess the safety and efficacy of MyoCell® therapy delivered via MyoCath® catheter..
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Myoheart (Phase I)

Phase I dose escalation study to assess safety, feasibility and efficacy...More Info >

Clinical Programs

MyoCell® Clinical Programs

U.S. Focused Clinical Trials

Clinical Trial	Number of Patients	Clinical Trial Sites	Objective	Status
MARVEL (Phase II/III Clinical Trial.)	330 anticipated, including 110 controls.	20 sites in the United States and Canada and up to 15 sites in Europe anticipated.	Designed to be a double-blind, randomized, placebo-controlled, multicenter trial to evaluate the safety and efficacy of MyoCell® delivered via MyoStar®.	MyoCell® implantation procedure completed on first patient in October 2007; six-month interim data anticipated in the second quarter of 2009 and final trial results anticipated in the fourth quarter of 2009.

MYOHEART (Phase I Clinical Trial)	20	Five sites in the United States	Phase I dose escalation study to assess safety, feasibility and efficacy of MyoCell® delivered via the MyoCath® catheter.	Trial commenced in 2003; treatment of all 20 patients completed in October 2006; final twelve-month data presented in January 2008.

Clinical Trial

Number of Patients

Clinical Trial Sites

Objective

Status

MARVEL

(Phase II/III Clinical Trial.)

330 anticipated, including 110 controls.

20 sites in the United States and Canada and up to 15 sites in Europe anticipated.

Designed to be a double-blind, randomized, placebo-controlled, multicenter trial to evaluate the safety and efficacy of MyoCell® delivered via MyoStar®.

MyoCell® implantation procedure completed on first patient in October 2007; six-month interim data anticipated in the second quarter of 2009 and final trial results anticipated in the fourth quarter of 2009.

MYOHEART

(Phase I Clinical Trial)

Five sites in the United States

Phase I dose escalation study to assess safety, feasibility and efficacy of MyoCell® delivered via the MyoCath® catheter.

Trial commenced in 2003; treatment of all 20 patients completed in October 2006; final twelve-month data presented in January 2008.

European Clinical Trials

Clinical Trial	Number of Patients	Clinical Trial Sites	Objective	Status
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.	Trial commenced in November 2005; treatment of all patients completed in July 2007; final results presented in April 2008.

Phase I/II Clinical Trial	15	Three sites in the Netherlands, Germany and Italy.	Phase I/II European study to assess the safety and efficacy of MyoCell®.	Trial commenced in 2002; twelve-month follow-up completed in June 2004.

Netherlands Pilot Trial	5	One site in the Netherlands.	Pilot study to assess safety and feasibility of MyoCell®.	Trial commenced in 2001; six-month follow-up completed in October 2003.

2002 Trial	3	One site in the Netherlands.	Designed to evaluate the safety and efficacy of MyoCell® delivered via the TransAccess catheter.	Trial commenced in 2002; discontinued upon Transvascular's acquisition by Medtronic.

Other Trials

Clinical Trial	Number of Patients	Clinical Trial Sites	Objective	Status
Partial Reimbursement Registry Studies	Up to 50 anticipated in the next two years.	Six sites in Korea, Mexico, Switzerland, The Bahamas, Singapore and South Africa anticipated.	Designed to generate additional safety and efficacy data and revenues.	Requisite regulatory approval to conduct trials recieved at all sites; contracts in place with an institution in each of Mexico, the Bahamas, Switzerland and Korea; MyoCell® implantation procedure completed for four patients in Korea and one patient in Mexico.