Cerebral PalsyPhase 2NCT02866331
G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
A Phase 2 study testing G-CSF (Leucostim) and CB (autologous cord blood) in people with Cerebral Palsy, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- G-CSF (Leucostim) and CB (autologous cord blood)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Dec 2018
- Phase
- Phase 2
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages from 2 years to 10 years at the time of enrollment
- Non-severe type of cerebral palsy
- Willing to comply with all study procedures
Who cannot join
- Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
- Presence of chromosomal abnormalities
- Unwillingness to participate clinical trial
- Presence of hypersensitivity reaction to G-CSF
- Evidence of hepatic, renal, cardiac dysfunctions
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Hospital
Seoul, Seoul, KS013
Young-Ho LEE, M.D., Ph.D., 82-2-2290-8383, cord@hanyang.ac.kr
About this study
Official title: Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy
This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.
- Conditions
- Cerebral Palsy
- Being tested
- G-CSF (Leucostim), CB (autologous cord blood), Placebo (Normal saline)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF (Leucostim)Drug
CB (autologous cord blood)Biological
Placebo (Normal saline)Drug
| Study group | Role | What they receive |
|---|---|---|
| CB + G-CSF | Experimental | Not described Receives: Drug: G-CSF (Leucostim); Biological: CB (autologous cord blood) |
| CB + placebo | Placebo comparator | Not described Receives: Biological: CB (autologous cord blood); Drug: Placebo (Normal saline) |
| G-CSF | Experimental | Not described Receives: Drug: G-CSF (Leucostim) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (Normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations
Measured: For 18 months from date of randomization
Secondary outcomes (1)
Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.
Measured: Every 6 months from date of randomization up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Young-Ho Lee, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866331
- Sponsor's protocol ID
- CP-CB-G-2016
- Status last verified
- Aug 2016
- First submitted
- 26 Jul 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02866331
- Acronym / sponsor ID
- CP-CB-G-2016
- Conditions
- Cerebral Palsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Jul 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Aug 2016 (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 study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CB + G-CSF | Experimental | Drug: G-CSF (Leucostim), Biological: CB (autologous cord blood) |
| CB + placebo | Placebo comparator | Biological: CB (autologous cord blood), Drug: Placebo (Normal saline) |
| G-CSF | Experimental | Drug: G-CSF (Leucostim) |
| Placebo | Placebo comparator | Drug: Placebo (Normal saline) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages from 2 years to 10 years at the time of enrollment
- Non-severe type of cerebral palsy
- Willing to comply with all study procedures
Key exclusion criteria (5 listed)
- Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
- Presence of chromosomal abnormalities
- Unwillingness to participate clinical trial
- Presence of hypersensitivity reaction to G-CSF
- Evidence of hepatic, renal, cardiac dysfunctions
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 |
|---|---|---|
| G-CSF (Leucostim) | Drug | CB + G-CSF, G-CSF |
| CB (autologous cord blood) | Biological | CB + G-CSF, CB + placebo |
| Placebo (Normal saline) | Drug | CB + placebo, Placebo |
Primary outcome
Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations
Time frame: For 18 months from date of randomization
1 secondary outcome
Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.
Time frame: Every 6 months from date of randomization up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-CSF (Leucostim) and CB (autologous cord blood) in people with Cerebral Palsy, run by Hanyang University Seoul Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Aug 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Ho LEE, M.D., Ph.D. (82-2-2290-8383, cord@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations (time frame: For 18 months from date of randomization). 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 15 Aug 2016.