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A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:
An Exploratory Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy

Clinical Trial Summary

UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.

Clinical Trial Description

This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04873752
Study type Interventional
Source Rohto Pharmaceutical Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 2, 2021
Completion date March 2024
View Details
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