search
Back to results

Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

Primary Purpose

Stroke, Umbilical Cord Blood, Erythropoietin

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Umbilical cord blood infusion
Erythropoietin injection
Placebo umbilical cord blood infusion
Placebo erythropoietin injection
Active rehabilitation
Sponsored by
Bundang CHA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bundang CHA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

UCB infusion and EPO injection group

UCB infusion and placebo EPO injection group

Placebo UCB infusion and placebo EPO injection group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Change of Medical research council
The difference in the MRC (Medical research council) scale between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences. [0, 1, 2, 2, 2+, 3-, 3, 3+, 4, 5] (The higher values represent a better outcome.)
Change of National Institutes of Health Stroke Scale
The difference in the NIHSS (National Institutes of Health Stroke Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~42] (The lower values represent a better outcome.)
Change of Manual Function Test
The difference in the MFT (Manual Function Test) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~32 for each arm] (The higher values represent a better outcome.)
Change of Fugl-Meyer Assessment
The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~66 for each arm] (The higher values represent a better outcome.)
Change of Berg Balance Scale
The difference in the BBS (Berg Balance Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~56] (The higher values represent a better outcome.)
Change of Trunk Imbalance Scale
The difference in the TIS (Trunk Imbalance Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~23] (The higher values represent a better outcome.)
Change of Korean Mini Mental State Exam
The difference in the K-MMSE (Korean Mini Mental State Exam) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences. [0~30] (The higher values represent a better outcome.)
Change of Korean Wechsler adult intelligence scale-IV
The difference in the K-WAIS-IV (Korean Wechsler adult intelligence scale-IV) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[The total score is a standard score with a mean of 100 and a standard deviation of approximately 15.] (The higher values represent a better outcome.)
Change of Korean version of the Western Aphasia Battery
The difference in the K-WAB (Korean version of the Western Aphasia Battery) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~100] (The higher values represent a better outcome.)
Change of Brain imaging
The difference in the Brain imaging (Basic brain MRI, functional brain MRI, diffusion tensor imaging brain MRI) between the three groups at baseline, and 180 days was confirmed by comparing differences.
Change of Biomarkers
The difference in the Biomarkers (TGFβ, IL-10, IL-8, PTX3, PCNT,...) between the three groups at baseline, 1 day, 15 days, 30 days, 90 days and 180 days was confirmed by comparing differences.

Full Information

First Posted
July 8, 2019
Last Updated
November 3, 2020
Sponsor
Bundang CHA Hospital
Collaborators
Korea Evaluation Institute of Industrial Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04013646
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
November 2, 2020 (Anticipated)
Study Completion Date
November 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
Collaborators
Korea Evaluation Institute of Industrial Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Umbilical Cord Blood, Erythropoietin, Safety, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCB infusion and EPO injection group
Arm Type
Experimental
Arm 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.
Arm Title
UCB infusion and placebo EPO injection group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo UCB infusion and placebo EPO injection group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Umbilical cord blood infusion
Other Intervention Name(s)
UCB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin injection
Other Intervention Name(s)
EPO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo umbilical cord blood infusion
Other Intervention Name(s)
pUCB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo erythropoietin injection
Other Intervention Name(s)
pEPO
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active rehabilitation
Other Intervention Name(s)
Rehabilitation
Intervention Description
Physical therapy and occupational therapy are performed daily.
Primary Outcome Measure Information:
Title
Change of Functional Independence Measure
Description
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 )
Time Frame
baseline - 3 months - 6 months
Secondary Outcome Measure Information:
Title
Change of Medical research council
Description
The difference in the MRC (Medical research council) scale between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences. [0, 1, 2, 2, 2+, 3-, 3, 3+, 4, 5] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of National Institutes of Health Stroke Scale
Description
The difference in the NIHSS (National Institutes of Health Stroke Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~42] (The lower values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Manual Function Test
Description
The difference in the MFT (Manual Function Test) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~32 for each arm] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Fugl-Meyer Assessment
Description
The difference in the FMA (Fugl-Meyer Assessment) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~66 for each arm] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Berg Balance Scale
Description
The difference in the BBS (Berg Balance Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~56] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Trunk Imbalance Scale
Description
The difference in the TIS (Trunk Imbalance Scale) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~23] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Korean Mini Mental State Exam
Description
The difference in the K-MMSE (Korean Mini Mental State Exam) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences. [0~30] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Korean Wechsler adult intelligence scale-IV
Description
The difference in the K-WAIS-IV (Korean Wechsler adult intelligence scale-IV) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[The total score is a standard score with a mean of 100 and a standard deviation of approximately 15.] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Korean version of the Western Aphasia Battery
Description
The difference in the K-WAB (Korean version of the Western Aphasia Battery) between the three groups at baseline, 90 days, and 180 days was confirmed by comparing differences.[0~100] (The higher values represent a better outcome.)
Time Frame
baseline - 3 months - 6 months
Title
Change of Brain imaging
Description
The difference in the Brain imaging (Basic brain MRI, functional brain MRI, diffusion tensor imaging brain MRI) between the three groups at baseline, and 180 days was confirmed by comparing differences.
Time Frame
baseline - 6 months
Title
Change of Biomarkers
Description
The difference in the Biomarkers (TGFβ, IL-10, IL-8, PTX3, PCNT,...) between the three groups at baseline, 1 day, 15 days, 30 days, 90 days and 180 days was confirmed by comparing differences.
Time Frame
baseline - 1 day - 15 days - 1 month - 3 months - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Moon Kim, MD
Phone
82-31-870-5456
Email
jmkim1013@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinYoung Kim, MD,PhD
Organizational Affiliation
CHA Bundang Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Bundang CHA Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Moon Kim, MD
Phone
+82-31-780-5456
Email
jmkim1013@gmail.com
First Name & Middle Initial & Last Name & Degree
Sun Hee Lee
Phone
+82-31-780-2954
Email
murkogi0@chamc.co.kr
First Name & Middle Initial & Last Name & Degree
MinYoung Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jong Moon Kim, MD
First Name & Middle Initial & Last Name & Degree
Wookyung Park, MD
First Name & Middle Initial & Last Name & Degree
Sun Hee Lee
First Name & Middle Initial & Last Name & Degree
Joonhyun Park, MD
First Name & Middle Initial & Last Name & Degree
Shinyoung Kwon, MD
First Name & Middle Initial & Last Name & Degree
Youngsu Jung, MD
First Name & Middle Initial & Last Name & Degree
Jaehoon Sim, MD
First Name & Middle Initial & Last Name & Degree
hyunseok Kwak, MD
First Name & Middle Initial & Last Name & Degree
Hyeon Jeong Oh
First Name & Middle Initial & Last Name & Degree
Jeong Seon Huh

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

We'll reach out to this number within 24 hrs