NCT04314687

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Oct 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

February 20, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 13, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

February 20, 2020

Last Update Submit

February 23, 2026

Conditions

Cerebral Palsy

Keywords

Allogeneic Mesenchymal Stem CellsUmbilical Cord Mesenchymal Stem CellsIntrathecal InjectionCerebral PalsyConditioned Medium

Outcome Measures

Primary Outcomes (6)

  • Gross Motor Function

    Gross Motor Function Classification System (GMFCS)

    3 month after stem cells

  • Gross Motor Function

    Gross Motor Function Classification System (GMFCS)

    6 month after stem cells

  • Gross Motor Function

    Gross Motor Function Measure (GMFM)

    3 month after stem cells

  • Gross Motor Function

    Gross Motor Function Measure (GMFM)

    6 month after stem cells

  • Cognitive Function

    Bayley Scales of Infant Development (BSID) version III

    3 month after stem cells

  • Cognitive Function

    Bayley Scales of Infant Development (BSID) version III

    6 month after stem cells

Secondary Outcomes (2)

  • Chemical Marker

    3 month after stem cells

  • Chemical Marker

    6 month after stem cells

Study Arms (3)

UCMSCs + CM

EXPERIMENTAL

UCMSCs + CM is administered via intrathecal injection

Biological: Umbilical Cord Mesenchymal Stem CellsBiological: Conditioned Medium

UCMSCs

EXPERIMENTAL

UCMSCs is administered via intrathecal injection

Biological: Umbilical Cord Mesenchymal Stem Cells

Standard Therapy

ACTIVE COMPARATOR

Physiotherapy

Other: Standard Therapy

Interventions

Conditioned MediumBIOLOGICAL

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.

Also known as: Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium
UCMSCs + CM
Standard TherapyOTHER

Standard therapy for cerebral palsy such as physiotherapy

Also known as: Physiotheraphy
Standard Therapy
Umbilical Cord Mesenchymal Stem CellsBIOLOGICAL

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.

Also known as: Allogeneic Mesenchymal Stem Cells
UCMSCsUCMSCs + CM

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indonesian National Brain Center

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Culture Media, ConditionedStandard of Care

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Culture MediaLaboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and UsesEquipment and SuppliesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 19, 2020

Study Start

October 13, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)