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StrokePhase 1/2NCT04013646

Combination Therapy of Umbilical Cord Blood and Erythropoietin for Stroke Paients

A Phase 1/2 study testing Umbilical cord blood infusion, Erythropoietin injection and Active rehabilitation in people with Stroke and Umbilical Cord Blood, run by Bundang CHA Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke, Umbilical Cord Blood, Erythropoietin
What is being tested?
Umbilical cord blood infusion, Erythropoietin injection and Active rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteSouth Korea
Study dates
2 May 2019to 2 Nov 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Jong Moon Kim, MD contact

82-31-870-5456

jmkim1013@gmail.com

South Korea1 site, 1 recruiting

  • Bundang CHA Medical Center

    Seongnam-si, Gyeonggi-do, 13496

    Jong Moon Kim, MD, +82-31-780-5456, jmkim1013@gmail.com

    Sun Hee Lee, +82-31-780-2954, murkogi0@chamc.co.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Safety and Efficacy of Combined Administration of Erythropoietin in Umbilical Cord Blood Therapy for Stroke Patients

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.

Read the 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.

Being tested
Umbilical cord blood infusion, Erythropoietin injection, Placebo umbilical cord blood infusion, Placebo erythropoietin injection, Active rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical cord blood infusionDrug

    Also called UCB

    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.

  • Erythropoietin injectionDrug

    Also called EPO

    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 infusionDrug

    Also called pUCB

    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 injectionDrug

    Also called pEPO

    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.

  • Active rehabilitationProcedure or surgery

    Also called Rehabilitation

    Physical therapy and occupational therapy are performed daily.

Study groups in NCT04013646
Study groupRoleWhat they receive
UCB infusion and EPO injection groupExperimentalTake 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.
Receives: Drug: Placebo umbilical cord blood infusion; Drug: Placebo erythropoietin injection; Procedure: Active rehabilitation
UCB infusion and placebo EPO injection groupExperimentalTake 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.
Receives: Drug: Umbilical cord blood infusion; Drug: Placebo erythropoietin injection; Procedure: Active rehabilitation
Placebo UCB infusion and placebo EPO injection groupPlacebo 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.
Receives: Drug: Umbilical cord blood infusion; Drug: Erythropoietin injection; Procedure: Active rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 )

    Measured: baseline - 3 months - 6 months

Secondary outcomes (11)

  1. 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.)

    Measured: baseline - 3 months - 6 months

  2. 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.)

    Measured: baseline - 3 months - 6 months

  3. 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.)

    Measured: baseline - 3 months - 6 months

  4. 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.)

    Measured: baseline - 3 months - 6 months

  5. 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.)

    Measured: baseline - 3 months - 6 months

  6. 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.)

    Measured: baseline - 3 months - 6 months

  7. 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.)

    Measured: baseline - 3 months - 6 months

  8. 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.)

    Measured: baseline - 3 months - 6 months

  9. 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.)

    Measured: baseline - 3 months - 6 months

  10. 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.

    Measured: baseline - 6 months

  11. 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.

    Measured: baseline - 1 day - 15 days - 1 month - 3 months - 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study start2 May 2019
  3. Primary completion2 Nov 2020 (estimated)
  4. Study completion2 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013646
Sponsor's protocol ID
2018-12-030
Status last verified
Nov 2020
First submitted
8 Jul 2019
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41456040

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Umbilical cord blood infusion, Erythropoietin injection and Active rehabilitation in people with Stroke and Umbilical Cord Blood, run by Bundang CHA Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jong Moon Kim, MD (82-31-870-5456, jmkim1013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Functional Independence Measure (time frame: baseline - 3 months - 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04013646, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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