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Clinical Trials and Recent Publications – U.S. Stem Cell, Inc

Clinical Trials and Recent Publications

Erratum to: Effects of the intradiscal implantation of stromal vascular fraction plus platelet-rich plasma in patients with degenerative disc disease. 

First-in-man Intravenous Implantation of Stromal Vascular Fraction in Psoriasis

Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels

Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction

Intraglandular Injection for the Treatment of Irradiation-Induced Gland Damage Post Cancer

Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability.

Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis.

Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy.

Integration of Stem Cell to Chondrocyte-Derived Cartilage Matrix in Healthy and Osteoarthritic States in the Presence of Hydroxyapatite Nanoparticles.

U.S. Trials

Title# of PatientsSitesObjectiveStatus
ANGEL Phase I Trial5 Patients Hospital Angeles Phase I study to assess safety and feasibility of AdipoCell™Enrollment Complete
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
MYOHEART (Phase I Clinical Trial)20Five sites in the United StatesTrials 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)153 Sites in USDesigned 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

Title# of PatientsSitesObjectiveStatus
2002 Trial 3 One site in the Netherlands Trial commenced in 2002. Discontinued upon Transvascular's acquisition by Medtronic.
Netherlands Phase I Clinical Trial 5 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. 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.