A Clinical Study of UC-MSCs for Pediatric Patients with Cerebral Palsy
- Conditions
- Pediatric cerebral palsy attributed to PV
- Registration Number
- JPRN-jRCT2053210009
- Lead Sponsor
- Ookawa Sumito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
1) Age >= 12 months and < 24 months corrected age at the time of informed consent
2) Diagnosed with cerebral palsy
3) Diagnosed with PVL
4) GMFCS level between II and IV
5) Able to obtain written infomed consent from parents (legal representative)
1) Presence of progressive neurological disease
2) Presence of congenital anomaly
3) Diagnosed with Grade 3 or more severe IVH
4) Body weight < 5kg
5) Profound intellectual disorder
6) Complication of serious infection such as sepsis
7) Requirement of mechanical ventilation
8) Complication of serious organ failure such as kidney, liver or heart diseases or others and considered to be inappropriate
9) Diagnosed with or suspected of hypsarrhythmia
10) Positive for HBV, HCV, HIV or HTLV-1
11) Patients who have recived cell therapy
12) Patients who have undergone SDR or received botulinum toxin products within a certain period of time
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events appeared in the participants after the treatment.
- Secondary Outcome Measures
Name Time Method 1) Difference and change in GMFM score<br>2) Improvement rate of GMFCS<br>3) Change in WeeFIM score<br>4) Change in and improvement rate of KSPD