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Active, Not Recruiting

NCT Number: NCT04314687

Stem Cell and Conditioned Medium for Cerebral Palsy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Indonesian National Brain Center

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

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 names: Allogeneic Mesenchymal Stem Cells

Conditioned Medium

Biological

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 names: Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium

Standard therapy

Other

Standard therapy for cerebral palsy such as physiotherapy

Other names: Physiotheraphy

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2020
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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