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ACTIVE NOT RECRUITING
NCT04314687
PHASE1/PHASE2

Stem Cell and Conditioned Medium for Cerebral Palsy

Sponsor: PT. Prodia Stem Cell Indonesia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Months - 3 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2021-10-13

Completion Date

2026-12

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

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.

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

Standard Therapy

Standard therapy for cerebral palsy such as physiotherapy

Locations (1)

Indonesian National Brain Center

Jakarta, Indonesia