Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP

NCT ID: NCT03979898

Last Updated: 2019-06-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-05-13

Brief Summary

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Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Detailed Description

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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Astrostem

Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Group Type EXPERIMENTAL

ASTROSTEM

Intervention Type BIOLOGICAL

Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10\^7cells/5mL 15kg \~ 25kg : 1x10\^8cells/10mL 25kg over : 1.5x10\^8cells/15mL

Interventions

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ASTROSTEM

Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10\^7cells/5mL 15kg \~ 25kg : 1x10\^8cells/10mL 25kg over : 1.5x10\^8cells/15mL

Intervention Type BIOLOGICAL

Other Intervention Names

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Autologous Adipose Tissue Derived Mesenchymal Stem Cells

Eligibility Criteria

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Inclusion Criteria

* Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
* Age : 36 months - 12 year, males and females
* Subjects who understand and sign the consent form for this study
* Kaufman Assessment Battery for Children 50\<K-ABC\<100

Exclusion Criteria

* The last three months had seizures or epilepsy patients taking the durg
* Genetic Diseases
* Recent cancer patients within 1 year
* patients witn a psychiatric disorder that may interfere in the clinical trial
* participating another clinical trials within 3 months
* Recently there is a change of the abrupt symptoms within three months of the patient
* Subjects with a infectious disease include HIV and VDRL
* Patients who penicillin hypersensitivity reactions
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Minimum Eligible Age

36 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

R-Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KyungHee University Gandong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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biostar-CP

Identifier Type: -

Identifier Source: org_study_id

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