Clinical trial NCT04013646: Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients
Official title: Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Umbilical Cord Blood
Erythropoietin
Safety
Treatment Outcome
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: Korea Evaluation Institute of Industrial Technology
First posted: 2019-07-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: UCB infusion and EPO injection group Group 2: UCB infusion and placebo EPO injection group Group 3: Placebo UCB infusion and placebo EPO injection group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Functional Independence Measure
timeFrame: baseline - 3 months - 6 months
Secondary outcomes:
measure: Change of Medical research council
timeFrame: baseline - 3 months - 6 months
measure: Change of National Institutes of Health Stroke Scale
timeFrame: baseline - 3 months - 6 months
measure: Change of Manual Function Test
timeFrame: baseline - 3 months - 6 months
measure: Change of Fugl-Meyer Assessment
timeFrame: baseline - 3 months - 6 months
measure: Change of Berg Balance Scale
timeFrame: baseline - 3 months - 6 months
measure: Change of Trunk Imbalance Scale
timeFrame: baseline - 3 months - 6 months
measure: Change of Korean Mini Mental State Exam
timeFrame: baseline - 3 months - 6 months
measure: Change of Korean Wechsler adult intelligence scale-IV
timeFrame: baseline - 3 months - 6 months
measure: Change of Korean version of the Western Aphasia Battery
timeFrame: baseline - 3 months - 6 months
measure: Change of Brain imaging
timeFrame: baseline - 6 months
measure: Change of Biomarkers
timeFrame: baseline - 1 day - 15 days - 1 month - 3 months - 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA Bundang Medical Center
name: MinYoung Kim, MD,PhD
role: STUDY_DIRECTOR
References: