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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 stroke
Started May 2019
Typical duration for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2019
CompletedFirst Submitted
Initial submission to the registry
July 8, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedNovember 5, 2020
November 1, 2020
1.5 years
July 8, 2019
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Functional Independence Measure
The difference in the FIM (Functional Independence Measure)score between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences in scores (total score\[18\~126\], motor score\[13\~90\], and cognition score\[5\~35\]. The total score is the sum of the motor score and the cognition score. The higher scores represent a better outcome )
baseline - 3 months - 6 months
Secondary Outcomes (11)
Change of Medical research council
baseline - 3 months - 6 months
Change of National Institutes of Health Stroke Scale
baseline - 3 months - 6 months
Change of Manual Function Test
baseline - 3 months - 6 months
Change of Fugl-Meyer Assessment
baseline - 3 months - 6 months
Change of Berg Balance Scale
baseline - 3 months - 6 months
- +6 more secondary outcomes
Study Arms (3)
UCB infusion and EPO injection group
EXPERIMENTALTake 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.
UCB infusion and placebo EPO injection group
EXPERIMENTALTake 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.
Placebo UCB infusion and placebo EPO injection group
PLACEBO COMPARATORTake 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Related Publications (1)
Kim JM, Shin S, Lee D, Choi JI, Kwon HG, Hwang SSS, Cho SM, Kim YH, Lee J, Moon HI, Suh MR, Kim M. Safety and efficacy of allogeneic umbilical cord blood cells and erythropoietin combination therapy in patients with subacute stroke. Stem Cell Res Ther. 2025 Dec 27;17(1):56. doi: 10.1186/s13287-025-04856-8.
PMID: 41456040DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MinYoung Kim, MD,PhD
CHA Bundang Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Rehabilitation Medicine Department, Professor, Principal Investigator
Study Record Dates
First Submitted
July 8, 2019
First Posted
July 10, 2019
Study Start
May 2, 2019
Primary Completion
November 2, 2020
Study Completion
November 2, 2021
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share