Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2013-11-26
2017-06-24
Brief Summary
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Detailed Description
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Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries. EPO is also known to have neuroprotective effects.
Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. EPO is combined to add synergistic effects to UCB therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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UCB and EPO
UCB + EPO + Rehabilitation
Umbilical Cord Blood therapy
HLA (Human Leukocyte Antigen) typing
Erythropoietin alfa
Rehabilitation
Active rehabilitation
UCB and placebo EPO
UCB + placebo EPO + Rehabilitation
Umbilical Cord Blood therapy
HLA (Human Leukocyte Antigen) typing
Rehabilitation
Active rehabilitation
Placebo EPO
placebo UCB and EPO
placebo UCB + EPO + Rehabilitation
Erythropoietin alfa
Rehabilitation
Active rehabilitation
Placebo UCB
placebo UCB and placebo EPO
placebo UCB + placebo EPO + Rehabilitation
Rehabilitation
Active rehabilitation
Placebo UCB
Placebo EPO
Interventions
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Umbilical Cord Blood therapy
HLA (Human Leukocyte Antigen) typing
Erythropoietin alfa
Rehabilitation
Active rehabilitation
Placebo UCB
Placebo EPO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age of ≥10 months and ≤6 years
* Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x107/kg. If the cell count is less than given values, more than 1 unit could be used.
* Hemoglobin ≤13.6 g/dL
* Decision of participation in the study by and acquisition of informed consent from the subject's representative
* Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry
Exclusion Criteria
* Known genetic disease
* History of hypersensitivity reaction to any study drugs pertinent to the study
* History of participation in any other study with stem cell
* Prior treatment with EPO within 3 months prior to study entry
* Known coagulopathy with family history of thrombosis or medical history of recurrent thrombosis
* Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
* Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
* Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotransferase (ALT) \>45 IU/L
* Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
* Absolute neutrophil count ≤500/dL
* Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
* Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient
10 Months
6 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
LG Life Sciences
INDUSTRY
Chong Kun Dang Pharmaceutical
INDUSTRY
CHA University
OTHER
MinYoung Kim, MD, PhD
OTHER
Responsible Party
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MinYoung Kim, MD, PhD
Professor of CHA University, M.D., Ph.D.
Principal Investigators
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MinYoung Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CHA University
Locations
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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Min K, Suh MR, Cho KH, Park W, Kang MS, Jang SJ, Kim SH, Rhie S, Choi JI, Kim HJ, Cha KY, Kim M. Potentiation of cord blood cell therapy with erythropoietin for children with CP: a 2 x 2 factorial randomized placebo-controlled trial. Stem Cell Res Ther. 2020 Nov 27;11(1):509. doi: 10.1186/s13287-020-02020-y.
Other Identifiers
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UCBnEPOinCP
Identifier Type: -
Identifier Source: org_study_id
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