Spastic Cerebral PalsyPhase 1NCT03107975
Effect of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
A Phase 1 study testing human amniotic epithelial cells in people with Spastic Cerebral Palsy, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- human amniotic epithelial cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent document;
- Gross Motor Function Classification System (GMFCS) levels III-V;
- Parents accepted voluntarily cell therapy for their children and followed-up.
Who cannot join
- Have a history of severe allergic;
- Serological tests such as AIDS, hepatitis B, syphilis, etc;
- Hereditary metabolic diseases of nervous system;
- Tumor or Hematological diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
About this study
Official title: Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.
Read the detailed description
Cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.Spastic cerebral palsy causes stiffness and movement difficulties.There is no cure for the disease now.
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. hAEC will be intrathecal transplanted. Functional status is determined by Gross Motor Function Measure-66 and Fine Motor Function Measure. Spasticity is evaluated by using modified Ashworth scale(MAS).
- Conditions
- Spastic Cerebral Palsy
- Being tested
- human amniotic epithelial cells
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human amniotic epithelial cellsBiological
intrathecal injection of human amniotic epithelial cells
| Study group | Role | What they receive |
|---|---|---|
| Cell Therapy | Experimental | intrathecal injection of human amniotic epithelial cells Receives: Biological: human amniotic epithelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-66
Gross Motor Function Measure-66 is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
Measured: 6 months
Secondary outcomes (3)
Fine Motor Function Measure
The fine motor performance is evaluated by using Fine Motor Function Measure.
Measured: 6 months
Modified Ashworth Scale
Spasticity is evaluated by using modified Ashworth scale.it is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: 6 months
Gesell Developmental Scales
Neurodevelopmental evaluation with the Gesell Developmental Schedules was performed.
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 posted11 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Hongzhi Gao, Dr., Principal investigator, The Second Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107975
- Sponsor's protocol ID
- SC-CP
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Transplant of Human Amniotic Epithelial Cells on Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03107975
- Acronym / sponsor ID
- SC-CP
- Conditions
- Spastic Cerebral Palsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Apr 2017 (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.
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy.
Detailed description
Cerebral palsy is one of the most common congenital (existing at or before birth) disorders of childhood.Spastic cerebral palsy causes stiffness and movement difficulties.There is no cure for the disease now.
This study aimed to evaluate the therapeutic potential of human amniotic epithelial cell (hAEC) transplant in the management of children with spastic cerebral palsy. hAEC will be intrathecal transplanted. Functional status is determined by Gross Motor Function Measure-66 and Fine Motor Function Measure. Spasticity is evaluated by using modified Ashworth scale(MAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell Therapy | Experimental | Biological: human amniotic epithelial cellsintrathecal injection of human amniotic epithelial cells |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Signed informed consent document;
- Gross Motor Function Classification System (GMFCS) levels III-V;
- Parents accepted voluntarily cell therapy for their children and followed-up.
Key exclusion criteria (4 listed)
- Have a history of severe allergic;
- Serological tests such as AIDS, hepatitis B, syphilis, etc;
- Hereditary metabolic diseases of nervous system;
- Tumor or Hematological diseases.
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 |
|---|---|---|
| human amniotic epithelial cellsintrathecal injection of human amniotic epithelial cells | Biological | Cell Therapy |
Primary outcome
Gross Motor Function Measure-66
Time frame: 6 months
Gross Motor Function Measure-66 is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
3 secondary outcomes
Fine Motor Function Measure
Time frame: 6 months
Modified Ashworth Scale
Time frame: 6 months
Gesell Developmental Scales
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Spastic Cerebral Palsy
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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
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Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
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Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Hongzhi Gao, Dr. principal investigator
The Second Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human amniotic epithelial cells in people with Spastic Cerebral Palsy, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
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 4 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 26 Apr 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 China. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Gross Motor Function Measure-66 (time frame: 6 months). 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 26 Apr 2017.