Title
Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients
Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients
Phase
Phase 1/Phase 2Lead Sponsor
Cha Medical UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Stroke Umbilical Cord Blood Erythropoietin Safety Treatment OutcomeIntervention/Treatment
Umbilical cord blood infusion Erythropoietin injection Placebo erythropoietin injection ...Study Participants
24This clinical trial is a clinical trial for the evaluation of the safety and efficacy of umbilical cord blood (UCB) therapy, UCB and erythropoietin (EPO) combination therapy in adult stroke patients.
UCB is a high-quality source of mesenchymal stem cells, and studies are being actively developed for stroke patients. UCB therapy has a neuroprotective effect through anti-inflammatory effect and anti-apoptosis.
However, UCB alone has not been able to provide sufficient improvement and is being studied for combination therapies with growth factors that can exert its effects. Among the various growth factors, EPO is a powerful factor that can act as a neurotrophic factor in neurons, astrocytes, oligodendrocytes, microglia, endothelial cells, and neural stem/precursor cells.
In our previous study of subacute stroke animal models, investigators confirmed that the combined administration of UCB and EPO improved the behavioral assessment (mNSS, Cylinder test) compared to UCB only administration.
The aim of this study is to investigate the difference in therapeutic effects between UCB alone therapy and UCB and EPO combination therapy.
The umbilical cord blood is donated umbilical cord blood which is stored in the cord blood bank donated by Cha Hospital. The total number of nuclear cells should be at least 2 x 10 7 / kg, and at least three out of six of the six human leukocyte antigens (HLA-A, B, DR) should be selected. The cord blood that matches ABO and Rh blood type is preferentially used. Umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
Recombinant human erythropoietin is used and is administered intravenously at a maximum of 5 times at a rate of 500 IU / kg 2 times/week after cord blood peripheral blood infusion, calculated as the dose per body weight. Or subcutaneous administration if intravenous administration is not possible. Store in a sealed container at 2-8 °C in the refrigerator before dosing. Erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
Placebo umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
Placebo erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
Physical therapy and occupational therapy are performed daily.
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin agent injects into the peripheral vein 5 times a total of 5 times a week.
Take immunosuppressant agents for 1 week. Umbilical cord blood is administered in the treatment room. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week.
Take immunosuppressant placebo for 1 week with the same schedule as the experimental group. As in the experimental group, placebo umbilical cord blood is administered in the treatment room and stay in the treatment room for the same time. Afterward, the venous erythropoietin placebo injects into the peripheral vein 5 times a total of 5 times a week. Other inspection schedules proceed with other groups.
Inclusion Criteria: Adult patients over 20 years old Patients with a stroke lasting from 30 days to less than 9 months After hearing and fully understanding the details of this clinical trial, the person or legal representative has agreed to voluntary participation and has agreed in writing to comply with the notice Exclusion Criteria: Patients with one or more of the following can not participate in the study. Patients with uncontrolled hypertension A person who has impaired ability of consent, who is not accompanied by a guardian Women who are pregnant, lactating, have a pregnancy plan during the trial, or those who do not use an available contraceptive method (women of childbearing age must be negative in the pregnancy test on baseline visit (0 weeks) .) Those who satisfy the following conditions A person whose ALT / AST is measured at 120 IU / L or more Serum creatinine greater than 1.8 mg / dL Total bilirubin> 1.8 mg / dL Total WBC count less than 3000 / mm3 Those with a Hb of 16 g / dL or more Platelet count less than 150,000 / uL or more than 675,000 / uL Clinically significant infections during the screening period (pneumonia, pyelonephritis, sepsis, etc.) Persons with severe medical conditions such as cardiovascular, digestive, respiratory, and endocrine conditions. Any kind of confirmed congenital or acquired immune deficiency syndrome Those who have been diagnosed with malignant carcinoma (excluding complete remission for more than 10 years) If participants have side effects on your medication [Regarding erythropoietin agent] Patients with hypersensitivity to erythropoietin Patients sensitive to mammalian cell-derived drugs or human albumin epileptic patients Patients with a history of seizures Patients on a thrombolytic drug (meaning thrombolytic agent such as Tissue Plasminogen Activator, allowing anti-platelet agents such as aspirin and plavix) [Related to tacrolimus] Patients with hypersensitivity to tacrolimus or macrolide compounds Patients receiving cyclosporine or bosentan Patients receiving potassium-preserving diuretics Other If the investigator determines that participation in this trial is not appropriate
