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Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

NCT ID: NCT01193660

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.

Detailed Description

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Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery.

It is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well.

Although autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved.

Conditions

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Cerebral Palsy

Keywords

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umbilical cord blood stem cell cerebral palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Umbilical Cord Blood & Erythropoietin & Rehabilitation

Allogenic umbilical cord blood infusion, erythropoietin injection \& active rehabilitation

Group Type EXPERIMENTAL

Umbilical Cord Blood Infusion

Intervention Type BIOLOGICAL

The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).

Erythropoietin Injection

Intervention Type DRUG

Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.

Active Rehabilitation

Intervention Type OTHER

All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

Erythropoietin & Rehabilitation

Erythropoietin injection, active rehabilitation

Group Type ACTIVE_COMPARATOR

Erythropoietin Injection

Intervention Type DRUG

Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.

Active Rehabilitation

Intervention Type OTHER

All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

Placebo Umbilical Cord Blood

Intervention Type OTHER

Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.

Only Rehabilitation

Active rehabilitation

Group Type PLACEBO_COMPARATOR

Active Rehabilitation

Intervention Type OTHER

All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

Placebo Umbilical Cord Blood

Intervention Type OTHER

Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.

Placebo Erythropoietin

Intervention Type OTHER

Placebo Erythropoietin containing Normal Saline

Interventions

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Umbilical Cord Blood Infusion

The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).

Intervention Type BIOLOGICAL

Erythropoietin Injection

Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.

Intervention Type DRUG

Active Rehabilitation

All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.

Intervention Type OTHER

Placebo Umbilical Cord Blood

Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.

Intervention Type OTHER

Placebo Erythropoietin

Placebo Erythropoietin containing Normal Saline

Intervention Type OTHER

Other Intervention Names

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Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank Brand name of Erythropoietin: Espogen (made by LG Life Science) Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin.

Eligibility Criteria

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Inclusion Criteria

* Known cerebral palsy
* Willing to comply with all study procedure

Exclusion Criteria

* High risk of pneumonia or renal function deterioration after using of immunosuppressant
* Presence of known genetic disease
* Possibility of drug hypersensitivity which is related to this study remedy
* History of previous cell therapy
* Poor cooperation of guardian,including inactive attitude for rehabilitation
* Intractable seizure disorder
* Autism
Minimum Eligible Age

10 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sung Kwang Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minyoung Kim, MD, PhD

Role: STUDY_CHAIR

CHA University

Locations

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CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PBC09-095

Identifier Type: OTHER

Identifier Source: secondary_id

RCTUBSC

Identifier Type: -

Identifier Source: org_study_id