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Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders

Primary Purpose

Brain Injury, Cerebral Palsy, Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Umbilical cord blood therapy

Filgrastim

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Umbilical cord blood, Granulocyte-colony stimulating factor, Brain injury, Neurodegenerative disorder, Efficacy, Safety

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: should be included one of the 4 disorders

Brain injury: onset duration over 12 months, Age: 19 years or over
Cerebral palsy: spastic, dyskinetic or ataxic, Age: 19 years or over
Parkinson's disease: modified Hoehn and Yahr stage 2.5, 3, 4, Age: 30 to 75 years
ALS: definite of possible ALS, progression during the past 6 months, Age: 19 to 65

Exclusion Criteria:

Uncontrolled pulmonary, renal dysfunction at enrollment
Uncontrolled seizure
Malignant cancer
Possibility of hypersensitivity to drugs used in this study
Contraindication to the study intervention or assessment
Pregnant or breast feeding women
Non-compliance with the study visits specified in the protocol

Sites / Locations

CHA Bundang Medical Center, CHA University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UCB + G-CSF

Arm Description

UCB + G-CSF

Outcomes

Primary Outcome Measures

Changes in Berg Balance Scale

Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)

Changes in the Level of Disability

FIM (Functional Independence Measure) for brain injury and cerebral palsy (range: 18 to 126, Higher scores indicate more independence in activities of daily living.)

Changes in Standardized Gross Motor Function

GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)

Changes in Motor Performance

GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)

Changes in ALSFRS-R

ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)

Changes in UPDRS

UPDRS (Unified Parkinson's Disease Rating Scale) for parkinson's disease (Part 1: mentation, behavior and mood; Part 2: activities of daily living; Part 3: motor examination; Part 4: complications of therapy; Part 5: Schwab and England activities of daily living scale)

Secondary Outcome Measures

Changes in Brain MRI

Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS

Changes in Brain PET

for parkinson's disease

Number of adverse events and participants with those adverse events

The numbers of adverse events and subjects with those serious adverse events within each group; A serious adverse event is any untoward medical occurrence that at any dose: results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or causes a congenital anomaly/birth defect.

Full Information

NCT ID

NCT02236065

First Posted

September 8, 2014

Last Updated

October 10, 2017

Sponsor

MinYoung Kim, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT02236065

Brief Title

Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders

Official Title

A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

MinYoung Kim, M.D.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (UCB) and granulocyte-colony stimulating factor (G-CSF) for patients with brain injury or neurodegenerative disorders.

Detailed Description

Current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. Preclinical and some clinical studies suggest that UCB and G-CSF can be used as restorative approach for such disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Parkinson's Disease

Keywords

Umbilical cord blood, Granulocyte-colony stimulating factor, Brain injury, Neurodegenerative disorder, Efficacy, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UCB + G-CSF

Arm Type

Experimental

Arm Description

UCB + G-CSF

Intervention Type

Procedure

Intervention Name(s)

Umbilical cord blood therapy

Intervention Type

Biological

Intervention Name(s)

Filgrastim

Primary Outcome Measure Information:

Title

Changes in Berg Balance Scale

Description

Berg Balance Scale for brain injury and parkinson's disease (range: 0 to 56, Higher scores indicates better balance function.)

Time Frame