Cerebral Palsy Clinical Trial
Official title:
Transplantation of Umbilical Cord-derived Mesenchymal Stem Cells Via Different Routes for the Treatment of Cerebral Palsy in Children
To preliminarily evaluate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSCs), and compare the efficacy of UC-MSCs administered through the intravenous, intrathecal, and intranasal routes, in the treatment of cerebral palsy in children.
Status | Not yet recruiting |
Enrollment | 44 |
Est. completion date | December 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with hypoxic/ischemic cerebral palsy, primarily including birth asphyxia and premature children - Patients with spastic quadriplegia - Patients with moderate to severe cerebral palsy, GMFM scores of 2-3 - Age at 2-18 years - Provision of signed informed consent by legal representatives of the child prior to start of the study Exclusion Criteria: - Those with systemic diseases that likely interfere with the treatment or child's compliance - Those complicated by life-threatening diseases of any organ - Those with brain deformity - Those with uncontrolled epilepsy - Those with abnormal behavior or mood disorders - Those with allergies especially those who are allergic to blood products - Those are infected with infectious diseases - Those who had underwent a craniocerebral surgery in other clinical trials |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Dalian Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Gross Motor Function Measure (GMFM)-88 item score | a 4-point scale that is divided into five categories including lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. A score of 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity); 3 indicates that the child completes the task (100%). The sum of score of the five categories is used as the evaluation outcome.It is used to evaluate gross motor function. | 12 months after 2 courses of treatment with UC-MSCs. | |
Secondary | Fine Motor Function Measure scale (FMFM) score | To evaluate fine motor function.The scale is divided into 45 items covering visual tracing (7 items), upper extremity range of motion (8 items), grab ability (8 items), operational ability (10 items), and hand-eye coordination (12 items). The FMFM is a 4-point scale with the score range of 0-3. The original total score is 135. The summed score for evaluating fine motor function measure is 0-100. | 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. | |
Secondary | The Modified Ashworth scale (MAS) score | To evaluate muscle tone. The MAS score is divided into six grades: 0, 1, 1+, 2, 3 and 4. Passive full ranges of motion exercises are performed by moving the knee and ankle until the patient feel a slight resistance from hamstrings and plantar flexor muscles (soleus muscle and gastrocnemius muscle). The average score is calculated across three repeated measurements. | 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. | |
Secondary | Gesell Development Schedule score | To evaluate neurobehavioral development. | 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. | |
Secondary | Incidence of adverse reactions | Liver and kidney dysfunction, fever, infection, vomiting. | 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |