Stem Cell and Conditioned Medium for Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Recruiting
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cells
Conditioned Medium
Standard Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Indonesian National Brain CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
UCMSCs + CM
UCMSCs
Standard Therapy
Arm Description
UCMSCs + CM is administered via intrathecal injection
UCMSCs is administered via intrathecal injection
Physiotherapy
Outcomes
Primary Outcome Measures
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Gross Motor Function
Gross Motor Function Classification System (GMFCS)
Gross Motor Function
Gross Motor Function Measure (GMFM)
Gross Motor Function
Gross Motor Function Measure (GMFM)
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Cognitive Function
Bayley Scales of Infant Development (BSID) version III
Secondary Outcome Measures
Chemical Marker
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Chemical Marker
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Full Information
NCT ID
NCT04314687
First Posted
February 20, 2020
Last Updated
June 12, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT04314687
Brief Title
Stem Cell and Conditioned Medium for Cerebral Palsy
Official Title
Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
September 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT. Prodia Stem Cell Indonesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intrathecal Injection, Cerebral Palsy, Conditioned Medium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UCMSCs + CM
Arm Type
Experimental
Arm Description
UCMSCs + CM is administered via intrathecal injection
Arm Title
UCMSCs
Arm Type
Experimental
Arm Description
UCMSCs is administered via intrathecal injection
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Physiotherapy
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells
Other Intervention Name(s)
Allogeneic Mesenchymal Stem Cells
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Conditioned Medium
Other Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Therapy
Other Intervention Name(s)
Physiotheraphy
Intervention Description
Standard therapy for cerebral palsy such as physiotherapy
Primary Outcome Measure Information:
Title
Gross Motor Function
Description
Gross Motor Function Classification System (GMFCS)
Time Frame
3 month after stem cells
Title
Gross Motor Function
Description
Gross Motor Function Classification System (GMFCS)
Time Frame
6 month after stem cells
Title
Gross Motor Function
Description
Gross Motor Function Measure (GMFM)
Time Frame
3 month after stem cells
Title
Gross Motor Function
Description
Gross Motor Function Measure (GMFM)
Time Frame
6 month after stem cells
Title
Cognitive Function
Description
Bayley Scales of Infant Development (BSID) version III
Time Frame
3 month after stem cells
Title
Cognitive Function
Description
Bayley Scales of Infant Development (BSID) version III
Time Frame
6 month after stem cells
Secondary Outcome Measure Information:
Title
Chemical Marker
Description
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Time Frame
3 month after stem cells
Title
Chemical Marker
Description
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
Time Frame
6 month after stem cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hardiono D. Pusponegoro
Phone
088293176579
Email
hardionodp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Retna Sartika
Email
c.sartika@gmail.com
Facility Information:
Facility Name
Indonesian National Brain Center
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Stem Cell and Conditioned Medium for Cerebral Palsy
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