Allogeneic Umbilical Cord Blood Therapy for Stroke

MinYoung Kim, M.D.

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Procedure: Allogeneic umbilical cord blood therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01884155

UCBStroke

Details and patient eligibility

About

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.

Full description

Stroke is one of the most common etiologies causing disability in developed countries. There remains no proven treatments except tissue plasminogen activator currently. Based on promising results of cell therapy in animal stroke models, efforts to apply cell therapy for patients with stroke has been made. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for stroke.

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic or hemorrhagic stroke
• Onset duration over 12 months
• Hemisphere lesions except brain stem and cerebellar lesions
• National Institute Health Stroke Scale: 10 to 15

Exclusion criteria

• Possibility of hypersensitivity drugs used in this study
• Uncontrolled hypertension or cardiovascualr diseases
• Malignant cancer
• Renal or hepatic dysfunction (Consultation to specialist in nephrology or gastroenterology in case of renal or hepatic dysfunction)
• Severe pulmonary dysfunction
• Traumatic brain injury
• Lack of matched UCB

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Allogeneic umbilical cord blood therapy

Experimental group

Description:

Allogeneic umbilical cord blood therapy

Treatment:

Procedure: Allogeneic umbilical cord blood therapy