Clinical Trials Worldwide

FOUR PIONEERING STUDIES in neurological disorders include a phase 1 study at the University of Texas Health Science Center at Houston that is evaluating the safety of autologous (using the patient's own cells) bone marrow treatments in 10 children aged 5–14 years with traumatic brain injury; a phase 1/2 study at the University of Cambridge to determine the safety and effectiveness of bone marrow—derived autologous mesenchymal stem cells in multiple sclerosis; a phase 1 safety study on the use of autologous bone marrow stem cells for acute stroke, sponsored by the Federal University of Rio de Janeiro in Brazil; and a recently completed phase 1 evaluation at Inha University in Incheon, Korea, where autologous bone marrow stem cells were used to treat acute and chronic spinal cord injuries. Thirty—five patients were treated in this study, and there were no serious adverse effects.

Azienda Unità Sanitaria Locale di Piacenza, in Italy, has been evaluating the safety of autologous bone marrow mononuclear cells for acute heart attack. Similar studies are under way at Nantes University Hospital in France, at Odense University Hospital in Denmark, at the University of Oulu in Finland, at the Minnesota Heart Institute in Minneapolis, and in a multicenter phase 3 national program in Brazil. Emory University in Atlanta, Georgia, is using autologous bone marrow CD34+ stem cells for acute heart attack. Rigs—hopitalet, in Denmark, is using autologous bone marrow—derived mesenchymal cells for treating severe chronic myocardial ischemia. Chronic damage from a heart attack is also being treated by BioCardia, Inc., in Buenos Aires, Argentina, and a similar study is in progress in Leiden University, Netherlands, and in a multicenter national program in Brazil.

The Texas Heart Institute is using autologous bone marrow mononuclear cell injections to help increase blood vessel development in patients with endstage ischémie cardiomyopathy, and the University of Pittsburgh in Pennsylvania is using autologous bone marrow progenitor cells for congestive heart failure.

Heinrich—Heine University in Duesseldorf, Germany, and Aastrom Biosciences, Inc., are using autologous bone marrow stem cells for peripheral artery disease, and CHU de Reims in Nantes, France, and the University of Naples in Italy are evaluating mononuclear cells for peripheral artery disease. The Franziskus Hospital in Berlin, Germany, is evaluating the use of autologous bone marrow treatments for critical, limb—threatening ischemia in a phase 2/3 study in patients with atherosclerosis or diabetes.

Researchers at the Federal University of Rio de Janiero, Brazil, are evaluating the safety of bone marrow—derived mononuclear cells in patients with liver cirrhosis. Shaheed Beheshti Medical University in Iran is sponsoring a phase 1/2 study of autologous bone marrow mesenchymal stem cells being differentiated into liver progenitor cells for end—stage liver disease.

Type 1 and type 2 diabetic patients are being treated at Shandong University in China with autologous bone marrow mononuclear cells infused directly into the pancreas. In wound healing, [Page 137]the University of Heidelberg in Germany is sponsoring a clinical trial using autologous bone marrow cells to treat diabetic ulcers and diabetic nonhealing wounds.

At Nagoya University in Japan, mesenchymal cells and mesenchymal—derived bone cells have been surgically implanted in 10 patients with periodontitis in a phase 1/2 clinical study. Osiris Therapeutics, Inc., in the United States is sponsoring a multicenter phase 2 study of its trademarked version of bone marrow—derived mesenchymal cells for intravenous infusion into patients with Crohn's disease.

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