Brain InjuryNCT02236065
Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders
A study testing Umbilical cord blood therapy and Filgrastim in people with Brain Injury and Cerebral Palsy, run by MinYoung Kim, M.D. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Brain Injury, Cerebral Palsy, Amyotrophic Lateral Sclerosis
- What is being tested?
- Umbilical cord blood therapy and Filgrastim
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
About this study
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
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.
Read the 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.
- Being tested
- Umbilical cord blood therapy, Filgrastim
- Keywords
- Umbilical cord blood, Granulocyte-colony stimulating factor, Brain injury, Neurodegenerative disorder, Efficacy, Safety
- Medical subject headings
- Brain Injuries, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Parkinson Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood therapyProcedure or surgery
FilgrastimBiological
| Study group | Role | What they receive |
|---|---|---|
| UCB + G-CSF | Experimental | UCB + G-CSF Receives: Procedure: Umbilical cord blood therapy; Biological: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Baseline - 1 month - 3 months - 6 months
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.)
Measured: Baseline - 1 month - 3 months - 6 months
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.)
Measured: Baseline - 1 month - 3 months - 6 months
Changes in Motor Performance
GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)
Measured: Baseline - 1 month - 3 months - 6 months
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.)
Measured: Baseline - 1 month - 3 months - 6 months
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)
Measured: Baseline - 1 month - 3 months - 6 months
Secondary outcomes (3)
Changes in Brain MRI
Analysis of Diffusion Tensor Image (DTI) for brain injury, cerebral palsy, ALS
Measured: Baseline - 6 months
Changes in Brain PET
for parkinson's disease
Measured: Baseline - 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MinYoung Kim, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MinYoung Kim, M.D., Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236065
- Sponsor's protocol ID
- UCBnG-CSF
- Status last verified
- Oct 2017
- First submitted
- 8 Sep 2014
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02236065
- Acronym / sponsor ID
- UCBnG-CSF
- Keywords
- Umbilical cord blood, Granulocyte-colony stimulating factor, Brain injury, Neurodegenerative disorder, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MinYoung Kim, M.D.University, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCB + G-CSF | Experimental | Procedure: Umbilical cord blood therapy, Biological: FilgrastimUCB + G-CSF |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood therapy | Procedure or surgery | UCB + G-CSF |
| Filgrastim | Biological | UCB + G-CSF |
Primary outcome
Changes in Berg Balance Scale
Time frame: Baseline - 1 month - 3 months - 6 months
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
Time frame: Baseline - 1 month - 3 months - 6 months
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
Time frame: Baseline - 1 month - 3 months - 6 months
GMFM (Gross Motor Function Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better gross motor function.)
Changes in Motor Performance
Time frame: Baseline - 1 month - 3 months - 6 months
GMPM (Gross Motor Performance Measure) for cerebral palsy (range: 0 to 100, Higher scores indicate better motor quality.)
Changes in ALSFRS-R
Time frame: Baseline - 1 month - 3 months - 6 months
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-revised) for ALS (range: 0 to 48, Higher scores indicate better physical function.)
Changes in UPDRS
Time frame: Baseline - 1 month - 3 months - 6 months
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)
3 secondary outcomes
Changes in Brain MRI
Time frame: Baseline - 6 months
Changes in Brain PET
Time frame: Baseline - 6 months
Number of adverse events and participants with those adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord blood therapy and Filgrastim in people with Brain Injury and Cerebral Palsy, run by MinYoung Kim, M.D. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Berg Balance Scale (time frame: Baseline - 1 month - 3 months - 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.