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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236065
• Other study ID #: UCBnG-CSF
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: October 10, 2017
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Brain Injuries
• Brain Injury
• Cerebral Palsy
• Motor Neuron Disease
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinson's Disease
• Wounds and Injuries

Intervention

Procedure:
• Umbilical cord blood therapy

Biological:
• Filgrastim

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
MinYoung Kim, M.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Baseline - 1 month - 3 months - 6 months
Primary	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.)	Baseline - 1 month - 3 months - 6 months
Primary	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.)	Baseline - 1 month - 3 months - 6 months
Primary	Changes in Motor Performance	GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)	Baseline - 1 month - 3 months - 6 months
Primary	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.)	Baseline - 1 month - 3 months - 6 months
Primary	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)	Baseline - 1 month - 3 months - 6 months
Secondary	Changes in Brain MRI	Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS	Baseline - 6 months
Secondary	Changes in Brain PET	for parkinson's disease	Baseline - 6 months
Secondary	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.	6 months