nct05004_1187_1194干细胞移植.pdfVIP

CLINICAL TRIALS SECTION EDITOR: IRA SHOULSON, MD Safety and Immunological Effects of Mesenchymal Stem Cell Transplantation in Patients With Multiple Sclerosis and Amyotrophic Lateral Sclerosis Dimitrios Karussis, MD, PhD; Clementine Karageorgiou, MD; Adi Vaknin-Dembinsky, MD, PhD; Basan Gowda-Kurkalli, PhD; John M. Gomori, MD; Ibrahim Kassis, MSc; Jeff W. M. Bulte, PhD; Panayiota Petrou, MD; Tamir Ben-Hur, MD, PhD; Oded Abramsky, MD, PhD; Shimon Slavin, MD Objective: To evaluate the feasibility, safety, and im- tests to assess the short-term immunomodulatory ef- munological effects of intrathecal and intravenous ad- fects of MSC transplantation. ministration of autologous mesenchymal stem cells (MSCs) (also called mesenchymal stromal cells) in pa- Results: Twenty-one patients had injection-related ad- tients with multiple sclerosis (MS) and amyotrophic lat- verse effects consisting of transient fever, and 15 re- eral sclerosis (ALS). ported headache. No major adverse effects were reported during follow-up. The mean ALSFRS score remained stable Design: A phase 1/2 open-safety clinical trial. during the first 6 months of observation, whereas the mean (SD) EDSS score improved from 6.7 (1.0) to 5.9 (1.6). Mag- Patients: Fifteen patients with MS (mean [SD] Ex- netic resonance imaging visualized the MSCs in the oc-