Status:
UNKNOWN
Stem Cell and Conditioned Medium for Cerebral Palsy
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Cerebral Palsy
Eligibility:
All Genders
6-3 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy. Hyp...
Eligibility Criteria
Inclusion
- Diagnosed as Cerebral palsy with total body involvement type
- Age between 6 month - 3 years old
- Parents requesting for cell therapy
- The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child
Exclusion
- Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
- Have diagnosed meningitis and encephalitis
- Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
- Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
- Progressive disorder
- Regressive development disorder
- Severe anatomical abnormalities in Brain MRI
Key Trial Info
Start Date :
October 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04314687
Start Date
October 13 2021
End Date
December 25 2023
Last Update
June 14 2022
Active Locations (1)
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1
Indonesian National Brain Center
Jakarta, Indonesia