Stem Cell and Conditioned Medium for Cerebral Palsy

Phase 1

• Conditions: Cerebral Palsy
• Interventions: Other: Standard Therapy; Biological: Umbilical Cord Mesenchymal Stem Cells; Biological: Conditioned Medium

• Registration Number: NCT04314687
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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 available

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2021-10-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-14
• Primary Completion: 2023-09-25
• Study Completion: 2023-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
UCMSCs + CM	Conditioned Medium	UCMSCs + CM is administered via intrathecal injection
Standard Therapy	Standard Therapy	Physiotherapy
UCMSCs	Umbilical Cord Mesenchymal Stem Cells	UCMSCs is administered via intrathecal injection
UCMSCs + CM	Umbilical Cord Mesenchymal Stem Cells	UCMSCs + CM is administered via intrathecal injection

Primary Outcome Measures

Name	Time	Method
Gross Motor Function	6 month after stem cells	Gross Motor Function Measure (GMFM)
Cognitive Function	6 month after stem cells	Bayley Scales of Infant Development (BSID) version III

Secondary Outcome Measures

Name	Time	Method
Chemical Marker	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)

Trial Locations

Locations (1)

Indonesian National Brain Center; 🇮🇩 Jakarta, Indonesia