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

MinYoung Kim, M.D.

Status: Completed

Conditions: Brain Injury; Parkinson's Disease; Cerebral Palsy; Amyotrophic Lateral Sclerosis

Treatments: Biological: Filgrastim; Procedure: Umbilical cord blood therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02236065

UCBnG-CSF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

UCB + G-CSF

Experimental group

Description:

UCB + G-CSF

Treatment:

Procedure: Umbilical cord blood therapy

Biological: Filgrastim