Review Article

Mesenchymal Stem Cells: Rising Concerns over Their Application in Treatment of Type One Diabetes Mellitus

Table 1


StudyYearIdentifierSite/principal investigatorIntervention Status/enrollment

“Treatment of Patients with Newly Onset of Type 1 Diabetes with Mesenchymal Stem Cells Phase I/II”2010NCT01068951Uppsala University HospitalAutologous transplantation of the patients’ own mesenchymal stem cells (approximately 2 × 106 cells/kg body weight) intravenouslyCompleted 2013; 20 patients

“PROCHYMAL (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) Phase I”2008NCT00690066Mesoblast International SàrlIntravenous infusion of ex vivo cultured adult human mesenchymal stem cells (PROCHYMAL)Completed 2011; 63 patients

“Umbilical Mesenchymal Stem Cells and Mononuclear Cells Infusion in Type 1 Diabetes Mellitus Phase I/II”2011NCT01374854Fuzhou General HospitalInfusion of 1 × 106/kg UCMSCs through pancreatic artery along with mononuclear cells by interventional therapy and another administration of same dose of UCMSCs one week after interventionActive, not recruiting; 44 patients

“Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients with Onset of Type 1 Diabetes Phase II/III”2010NCT01157403Lu Debin, Third Military Medical UniversityAutologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 × 106 cells/kg body weight) intravenouslyRecruiting; 80 patients

“Safety and Efficacy of Mesenchymal Stem Cells in Newly Diagnosed Type 1 Diabetic Patients Phase I/II”2010NCT01322789University of Sao PauloIntravenous mesenchymal stem cell infusion; four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apartRecruiting; 10 patients

“Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients Phase I/II”2008NCT00646724Fuzhou General HospitalCotransplantation of islet and mesenchymal stem cell; islet of allograft and MSCs of autograftRecruiting; 30 patients

“Human Menstrual Blood-Derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients Phase I/II”2011NCT01496339S-Evans Biosciences Co., Ltd.1 × 106/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapiesRecruiting; 50 patients

“Stem Cell Therapy for Type 1 Diabetes Mellitus Phase I/II”2010NCT01143168Cellonis Biotechnology Co.First transplantation: on day 0, ABM-MNCs + UCMSCs through pancreas artery; second transplantation: on day 7 ± 1, ABM-MNCs + UCMSCs intravenously; third transplantation: on day 14 ± 2, ABM-MNCs + UCMSCs intravenouslyActive, not recruiting; 24 patients

“Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: A Blinded Randomized Study Phase II”2014NCT02057211Uppsala University HospitalAutologous mesenchymal stem cell transplantationRecruiting; 50 patients

ABM-MNCs: autologous bone marrow mononuclear cells, UCMSCs: umbilical cord mesenchymal stem cells, and MenSCs: menstrual blood-derived mesenchymal stem cells.