NCT02433509

Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.

Detailed description

The study will use Umbilical Cord Blood cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 4 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. Then cells injection by Intravenous in acute ischemic stroke patients.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
OTHER	hUCB	1. The cord blood need to be infusion within less than 10 days after the onset of stroke, and the cord blood mononuclear cells 200 million \~ 500 million will used. 2. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .

Timeline

• Start date: 2015-05-01
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2015-05-05
• Last updated: 2025-08-06

Locations

1 site across 1 country: Taiwan