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Stem Cell and Conditioned Medium for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT04314687
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date June 4, 2020
Estimated Study Start Date  ICMJE June 25, 2020
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • Gross Motor Function [ Time Frame: 3 month after stem cells ]
    Gross Motor Function Classification System (GMFCS)
  • Gross Motor Function [ Time Frame: 6 month after stem cells ]
    Gross Motor Function Classification System (GMFCS)
  • Gross Motor Function [ Time Frame: 3 month after stem cells ]
    Gross Motor Function Measure (GMFM)
  • Gross Motor Function [ Time Frame: 6 month after stem cells ]
    Gross Motor Function Measure (GMFM)
  • Cognitive Function [ Time Frame: 3 month after stem cells ]
    Bayley Scales of Infant Development (BSID) version III
  • Cognitive Function [ Time Frame: 6 month after stem cells ]
    Bayley Scales of Infant Development (BSID) version III
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • Chemical Marker [ Time Frame: 3 month after stem cells ]
    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 [ Time Frame: 6 month after stem cells ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell and Conditioned Medium for Cerebral Palsy
Official Title  ICMJE Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Biological: 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.
    Other Name: Allogeneic Mesenchymal Stem Cells
  • Biological: 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.
    Other Name: Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium
  • Other: Standard Therapy
    Standard therapy for cerebral palsy such as physiotherapy
    Other Name: Physiotheraphy
Study Arms  ICMJE
  • Experimental: UCMSCs + CM
    UCMSCs + CM is administered via intrathecal injection
    Interventions:
    • Biological: Umbilical Cord Mesenchymal Stem Cells
    • Biological: Conditioned Medium
  • Experimental: UCMSCs
    UCMSCs is administered via intrathecal injection
    Intervention: Biological: Umbilical Cord Mesenchymal Stem Cells
  • Active Comparator: Standard Therapy
    Physiotherapy
    Intervention: Other: Standard Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 25, 2020
Estimated Primary Completion Date September 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hardiono D. Pusponegoro 088293176579 hardionodp@gmail.com
Contact: Cynthia Retna Sartika c.sartika@gmail.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04314687
Other Study ID Numbers  ICMJE CT/CP/02/2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PT. Prodia Stem Cell Indonesia
Study Sponsor  ICMJE PT. Prodia Stem Cell Indonesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PT. Prodia Stem Cell Indonesia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP