Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial

• Published in: Trials Vol. 14; no. 1; p. 317
• Main Authors: Kim, Suk Jae, Moon, Gyeong Joon, Chang, Won Hyuk, Kim, Yun-Hee, Bang, Oh Young
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 01.10.2013; BioMed Central
• Subjects: Acute Disease; Care and treatment; Cells, Cultured; Chronic Disease; Clinical Protocols; Health aspects; Humans; Infusions, Intravenous; Ischemia; Magnetic Resonance Imaging; Mesenchymal Stem Cell Transplantation - methods; Mesenchymal Stem Cells - metabolism; Physiological aspects; Prospective Studies; Recovery of Function; Research Design; Risk factors; Serum - metabolism; Stem cells; Stroke (Disease); Stroke - blood; Stroke - diagnosis; Stroke - physiopathology; Stroke - surgery; Study Protocol; Time Factors; Transplantation; Transplantation, Autologous; Treatment Outcome; South Korea
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-14-317

Recovery after a major stroke is usually limited, but cell therapy for patients with fixed neurologic deficits is emerging. Several recent clinical trials have investigated mesenchymal stem cell (MSC) therapy for patients with ischemic stroke. We previously reported the results of a controlled trial on the application of autologous MSCs in patients with ischemic stroke with a long-term follow-up of up to 5 years (the 'STem cell Application Researches and Trials In NeuroloGy' (STARTING) study). The results from this pilot trial are challenging, but also raise important issues. In addition, there have been recent efforts to improve the safety and efficacy of MSC therapy for stroke. The clinical and preclinical background and the STARTING-2 study protocol are provided. The trial is a prospective, randomized, open-label, blinded-endpoint (PROBE) clinical trial. Both acute and chronic stroke patients will be selected based on clinical and radiological features and followed for 3 months after MSC treatment. The subjects will be randomized into one of two groups: (A) a MSC group (n = 40) or (B) a control group (n = 20). Autologous MSCs will be intravenously administered after ex vivo culture expansion with autologous ischemic serum obtained as early as possible, to enhance the therapeutic efficacy (ischemic preconditioning). Objective outcome measurements will be performed using multimodal MRI and detailed functional assessments by blinded observers. This trial is the first to evaluate the efficacy of MSCs in patients with ischemic stroke. The results may provide better evidence for the effectiveness of MSC therapy in patients with ischemic stroke. This trial was registered with ClinicalTrials.gov, number NCT01716481.