- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03005249
Neural Stem Cells Therapy for Cerebral Palsy
August 27, 2018 updated by: Liu Jing, The First Affiliated Hospital of Dalian Medical University
Neural Stem Cells Therapy for Cerebral Palsy: a Prospective, Randomized, Parallel-controlled Trial
To evaluate the safety and efficacy of neural stem cells (NSCs) therapy for cerebral palsy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy is the most severe lifelong disability disease in childhood.
In China, an epidemiological investigation of cerebral palsy in 2004 has reported that 2.74‰ (about 6.50-9.75 million) of children suffered from cerebral palsy.
The costs of medical expenses, living allowance and nursing care can go up to RMB 20000-50000 yuan per year for each child with cerebral palsy and thus China will expend RMB 120-300 billion yuan per year for children with cerebral palsy.
With full liberalization of two-child policy, there is an increasing number of second babies born to women who are 35 years or older.
Thus, the incidence of cerebral palsy tends to increase.
There is currently no cure for cerebral palsy, resulting in a heavy burden for families and on society.
Recent clinical trials performed in countries outside China have demonstrated that stem cell therapy is likely the most effective method to treat cerebral palsy.
Fifteen trials regarding stem cell therapy for cerebral palsy have been registered with ClinicalTrials.gov.
In China, there have been no standardized registered trials regarding stem cell therapy for cerebral palsy, which greatly restricts its clinical application.
In October 2016, the National Health and Family Planning Commission and the Food and Drug Administration of China jointly announced the premier stem cell clinical research institutions, making performing standardized trials regarding stem cell therapy for cerebral palsy in China possible.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
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Dalian, Liaoning, China, 116011
- Recruiting
- The First Affiliated Hospital of Dalian Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neonates with ischemic/hypoxic cerebral palsy (mainly including neonate with asphyxia and premature infants);
- Clinical manifestation of spastic tetraplegia;
- With moderate to severe cerebral palsy, The Gross Motor Function; Classification System (GMFCS) levels IV-V;
- Age 1-5 years, of either sex;
- Provision of signed informed consent by one of his/her parents or legal guardians prior to commencement of this study;
Exclusion Criteria:
- Systemic diseases that possibly influence treatment or patient's compliance;
- Potentially life-threatening diseases involving various organ systems;
- Brain deformity;
- Abnormal behaviors or mood disorder;
- Allergies from blood products;
- Suffering from infectious disease;
- Subjected to craniocerebral operations prior to screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: neural stem cells therapy group
The patients will be assigned to neural stem cells therapy group for cerebral palsy.
|
The patients will be assigned to neural stem cells therapy group for cerebral palsy.
|
Experimental: the control group
The patients will be assigned to the control group for cerebral palsy.
|
The patients will be assigned to the control group for cerebral palsy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMFM-88 score
Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
To evaluate change in gross motor function in children with cerebral palsy.
|
changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fine Motor Function Measure (FMFM) score
Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
To evaluate change in fine motor function in children with cerebral palsy.
|
changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
Modified Ashworth Scale score
Time Frame: changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
To measure resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.
|
changes of month 1, month 3, month 6, month 9 and month 12 after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
December 26, 2016
First Submitted That Met QC Criteria
December 26, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCKY2016-60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
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Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on neural stem cells therapy group
-
StemCells, Inc.WithdrawnNeuronal Ceroid LipofuscinosisUnited States
-
Azienda Ospedaliera Santa Maria, Terni, ItalyAzienda Ospedaliero Universitaria Maggiore della Carita; Università di Padova...CompletedAmyotrophic Lateral SclerosisItaly
-
IRCCS San RaffaeleFondazione Italiana Sclerosi MultiplaCompletedProgressive Multiple SclerosisItaly
-
Gary Steinberg, MD, PhDCalifornia Institute for Regenerative Medicine (CIRM)RecruitingIschemic StrokeUnited States
-
Casa Sollievo della Sofferenza IRCCSNeurocenter of Southern Switzerland; Associazione Revert ONLUS; Fondazione Cellule...CompletedSecondary-progressive Multiple SclerosisItaly, Switzerland
-
ReNeuron LimitedCompleted
-
NeuroGenerationWithdrawn
-
Allife Medical Science and Technology Co., Ltd.UnknownStroke, Ischemic
-
Chinese Academy of SciencesAffiliated Hospital of Logistics University of CAPFUnknownSpinal Cord InjuryChina
-
StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada