NCT04314687

Stem Cell and Conditioned Medium for Cerebral Palsy

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: PT. Prodia Stem Cell Indonesia · Industry
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-13
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2020-03-19
• Last updated: 2026-02-25

Locations

1 site across 1 country: Indonesia