Cerebral PalsyEarly Phase 1CPNCT03979898
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
A Early Phase 1 study testing ASTROSTEM in people with Cerebral Palsy, run by R-Bio at 1 site in South Korea.
Trial summary
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP Read more about this study
- Who is it for?
- Ages 36 months to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ASTROSTEM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2017to 13 May 2019
- Phase
- Early Phase 1
- 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 36 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
- Age : 36 months - 12 year, males and females
- Subjects who understand and sign the consent form for this study
- Kaufman Assessment Battery for Children 50<K-ABC<100
Who cannot join
- The last three months had seizures or epilepsy patients taking the durg
- Genetic Diseases
- Recent cancer patients within 1 year
- patients witn a psychiatric disorder that may interfere in the clinical trial
- participating another clinical trials within 3 months
- Recently there is a change of the abrupt symptoms within three months of the patient
Show all 9Show fewer
- Subjects with a infectious disease include HIV and VDRL
- Patients who penicillin hypersensitivity reactions
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
Read the detailed description
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)
- Conditions
- Cerebral Palsy
- Being tested
- ASTROSTEM
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTROSTEMBiological
Also called Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
| Study group | Role | What they receive |
|---|---|---|
| Astrostem | Experimental | Autologous Adipose Tissue Derived Mesenchymal Stem Cells Receives: Biological: ASTROSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaufman Assessment Battery for Children (K-ABC)
Change from Baseline K-ABC at 12 months
Measured: Baseline and 12 month
Secondary outcomes (7)
Blood concentration test
Change from baseline concentration of dopamine, acetylcholine, serotonin at 1, 3, 6 and 12 month
Measured: Baseline, 1, 3, 6 and 12 month
Gross Motor Function Measurement (GMFM)
Change from Baseline GMFM at 12 months
Measured: Baseline, 3, 6 and 12 month
Box and Block Test
Change from Baseline Box and block test at 12 months
Measured: Baseline, 3, 6 and 12 month
Modified Ashworth Scale (MAS)
- Measurement of resistance during soft-tissue stretching
- Scale range is 0(no increase in muscle ton) to 4(affected part rigid in flexion or extension)
- Change from Baseline MAS at 12 months
Measured: Baseline, 3, 6 and 12 month
SF-36
- SF-36 is a survey to measure Mental \& Physical Health
- Score range is 0 to 100(the lower the score, the more disability)
- Change from Baseline SF-36 at 12 months
Measured: Baseline, 3, 6 and 12 month
Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan
Changes in fMRI \& MRS scan from baseline to 6, 12 month
Measured: Baseline, 6 and 12 month
Kaufman Assessment Battery for Children (K-ABC)
Change from Baseline K-ABC at 6 months
Measured: Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start15 Jun 2017
- Primary completion23 Apr 2019
- Study completion13 May 2019
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979898
- Sponsor's protocol ID
- biostar-CP
- Acronym
- CP
- Status last verified
- Jun 2019
- First submitted
- 1 Aug 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
- ClinicalTrials.gov ID
- NCT03979898
- Acronym / sponsor ID
- CP / biostar-CP
- Conditions
- Cerebral Palsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- 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.
Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
Detailed description
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Astrostem | Experimental | Biological: ASTROSTEMAutologous Adipose Tissue Derived Mesenchymal Stem Cells |
Who may qualify
- Ages
- 36 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
- Age : 36 months - 12 year, males and females
- Subjects who understand and sign the consent form for this study
- Kaufman Assessment Battery for Children 50<K-ABC<100
Key exclusion criteria (9 listed)
- The last three months had seizures or epilepsy patients taking the durg
- Genetic Diseases
- Recent cancer patients within 1 year
- patients witn a psychiatric disorder that may interfere in the clinical trial
- participating another clinical trials within 3 months
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 |
|---|---|---|
| ASTROSTEMAlso: Autologous Adipose Tissue Derived Mesenchymal Stem CellsIntravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL | Biological | Astrostem |
Primary outcome
Kaufman Assessment Battery for Children (K-ABC)
Time frame: Baseline and 12 month
Change from Baseline K-ABC at 12 months
7 secondary outcomes
Blood concentration test
Time frame: Baseline, 1, 3, 6 and 12 month
Gross Motor Function Measurement (GMFM)
Time frame: Baseline, 3, 6 and 12 month
Box and Block Test
Time frame: Baseline, 3, 6 and 12 month
Modified Ashworth Scale (MAS)
Time frame: Baseline, 3, 6 and 12 month
SF-36
Time frame: Baseline, 3, 6 and 12 month
Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan
Time frame: Baseline, 6 and 12 month
Kaufman Assessment Battery for Children (K-ABC)
Time frame: Baseline and 6 month
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 7 Jun 2019.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing ASTROSTEM in people with Cerebral Palsy, run by R-Bio 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 4 inclusion and 9 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 7 Jun 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Kaufman Assessment Battery for Children (K-ABC) (time frame: Baseline and 12 month). 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 7 Jun 2019.