Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

Bundang CHA Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Umbilical Cord Blood; Stroke; Treatment Outcome; Erythropoietin; Safety

Treatments: Drug: Placebo umbilical cord blood infusion; Drug: Umbilical cord blood infusion; Procedure: Active rehabilitation; Drug: Placebo erythropoietin injection; Drug: Erythropoietin injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04013646

2018-12-030

Details and patient eligibility

About

This 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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients over 20 years old
2. Patients with a stroke lasting from 30 days to less than 9 months
3. 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.

1. Patients with uncontrolled hypertension

2. A person who has impaired ability of consent, who is not accompanied by a guardian

3. 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) .)

4. 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

5. Clinically significant infections during the screening period (pneumonia, pyelonephritis, sepsis, etc.)

6. Persons with severe medical conditions such as cardiovascular, digestive, respiratory, and endocrine conditions.

7. Any kind of confirmed congenital or acquired immune deficiency syndrome

8. Those who have been diagnosed with malignant carcinoma (excluding complete remission for more than 10 years)

9. 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

10. Other If the investigator determines that participation in this trial is not appropriate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

UCB infusion and EPO injection group

Experimental group

Description:

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.

Treatment:

Drug: Placebo erythropoietin injection

Procedure: Active rehabilitation

Drug: Placebo umbilical cord blood infusion

UCB infusion and placebo EPO injection group

Experimental group

Description:

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.

Treatment:

Drug: Placebo erythropoietin injection

Procedure: Active rehabilitation

Drug: Umbilical cord blood infusion

Placebo UCB infusion and placebo EPO injection group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Erythropoietin injection

Procedure: Active rehabilitation

Drug: Umbilical cord blood infusion