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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 14, 2022
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: Umbilical Cord Mesenchymal Stem Cells Biological: Conditioned Medium Other: Standard Therapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : September 25, 2023
Estimated Study Completion Date : December 25, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
 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
Experimental: UCMSCs
UCMSCs is administered via intrathecal injection
 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
Active Comparator: Standard Therapy
Physiotherapy
 Other: Standard Therapy
Standard therapy for cerebral palsy such as physiotherapy
Other Name: Physiotheraphy


Outcome Measures
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Primary Outcome Measures :
  1. Gross Motor Function [ Time Frame: 3 month after stem cells ]
    Gross Motor Function Classification System (GMFCS)

  2. Gross Motor Function [ Time Frame: 6 month after stem cells ]
    Gross Motor Function Classification System (GMFCS)

  3. Gross Motor Function [ Time Frame: 3 month after stem cells ]
    Gross Motor Function Measure (GMFM)

  4. Gross Motor Function [ Time Frame: 6 month after stem cells ]
    Gross Motor Function Measure (GMFM)

  5. Cognitive Function [ Time Frame: 3 month after stem cells ]
    Bayley Scales of Infant Development (BSID) version III

  6. Cognitive Function [ Time Frame: 6 month after stem cells ]
    Bayley Scales of Infant Development (BSID) version III


Secondary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314687


Contacts
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Contact: Hardiono D. Pusponegoro 088293176579 hardionodp@gmail.com
Contact: Cynthia Retna Sartika c.sartika@gmail.com

Locations
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Indonesia
Indonesian National Brain Center Recruiting
Jakarta, Indonesia
Sponsors and Collaborators
PT. Prodia Stem Cell Indonesia
More Information
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04314687    
Other Study ID Numbers: CT/CP/02/2020
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PT. Prodia Stem Cell Indonesia:
Allogeneic Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
Intrathecal Injection
Cerebral Palsy
Conditioned Medium
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases