Our principal objective is to become a leading company that discovers, develops and commercializes novel, autologous cell therapies and related devices, for the treatment of chronic and acute heart damage. more...
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 >
MyoCell® Clinical Programs
Clinical Trials Conducted for US FDA Approval
The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with advanced heart failure after receiving injection of adult muscle stem cell therapy in their damaged heart muscle. We have been cleared by the U.S. Food and Drug Administration (the “FDA”) to proceed with a multicenter Phase II/III trial of MyoCell® in North America and Europe (the “MARVEL Trial”). The MARVEL Study is partitioned into two stages: MARVEL Part 1 and MARVEL Part 2. MARVEL Part 1 is complete and the data on the first 20 patients was analyzed and presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Boston, Massachusetts. The data displayed overall positive clinical results.
If the results of the MARVEL Clinical Program demonstrate statistically significant evidence of the safety and efficacy of MyoCell, we anticipate having a basis to ask the FDA to consider the MARVEL Trial a pivotal trial.
If the REGEN Trial exhibits the same level of increased efficacy vs. MyoCell alone in humans as was seen in animals, consideration will be given to including MyoCell with SDF-1 in the MARVEL trial, which is currently on hold pending the REGEN Trial.
The SEISMIC (European), MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue from the sale of MyoCell cell-culturing services for treatment of patients by interventional cardiologists.
| Clinical Trial | Number of Patients | Clinical Trial Sites | Objective | Status |
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MARVEL (Phase II/III Clinical Trial.) |
MARVEL Part 1: 20 Patients (Completed) MARVEL Part 2: 150 Patients |
35 sites in North America and Europe. | 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. 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 results. MARVEL Part 2 on hold pending results of REGEN trial. |
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(Phase I Clinical Trial) |
15 | 2 sites in Jordan | Designed to be an open-label, multicenter, dose escalation trial to evaluate the safety and cardiovascular effects of MyoCell® with SDF-1 delivered via MyoCath®. |
Approval received in July of 2009 from the FDA to move forward with the trial. Work commenced during the first quarter of 2010. |
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(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. |
European Clinical Trials
| Clinical Trial | Number of Patients | Clinical Trial Sites | Objective | Status |
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(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. |
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| 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. |
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| 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. |
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| 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. |