NCT04873752

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Rohto Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cerebral Palsy
• Periventricular Leukomalacia

Interventions

Type	Name	Description
BIOLOGICAL	UDI-001	2.5 x 10\^6 cells/kg of UDI-001 are administered intravenously. One cycle consists of twice a week administrations.

Timeline

• Start date: 2021-06-02
• Primary completion: 2023-07-12
• Completion: 2024-02-15
• First posted: 2021-05-05
• Last updated: 2025-04-06

Locations

1 site across 1 country: Japan