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

China Medical University

Status and phase: Completed; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Other: hUCB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02433509

CMUH101-IRB1-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age of Subjects between 45 through 80 years.
2. Acute Ischemic Stroke.
3. National Institutes of Health Stroke Scale (NIHSS):6-18
4. Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients.
5. Subjects have no midline shift or hemorrhagic transformation

Exclusion criteria

1. NIHSS score reduced more than 4 within after 24 hours.
2. Female are pregnant or lactating.
3. Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease)
4. Subjects joined other clinical trails or received rt-PA therapy.
5. Immune dysfunction or receiving other immunosuppressive agents.
6. Subjects cannot have MRI test
7. Subjects' HLA typing results match less than 4 out of the 6 genotypes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

hUCB w/ Mannitol in acute ischemic stroke

Experimental group

Description:

1. The cord blood need to be infusion within less than 10 days after the onset of stroke, with 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 .

Treatment:

Other: hUCB