Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2021-10-13
2023-12-25
Brief Summary
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Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
Umbilical Cord Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Conditioned Medium
Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product.
UCMSCs
UCMSCs is administered via intrathecal injection
Umbilical Cord Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Standard Therapy
Physiotherapy
Standard Therapy
Standard therapy for cerebral palsy such as physiotherapy
Interventions
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Umbilical Cord Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Conditioned Medium
Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product.
Standard Therapy
Standard therapy for cerebral palsy such as physiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Months
3 Years
ALL
No
Sponsors
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PT. Prodia Stem Cell Indonesia
INDUSTRY
Responsible Party
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Locations
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Indonesian National Brain Center
Jakarta, , Indonesia
Countries
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Central Contacts
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Other Identifiers
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CT/CP/02/2020
Identifier Type: -
Identifier Source: org_study_id
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