Overview

This trial is active, not recruiting.

Condition stroke
Treatment allogeneic umbilical cord blood therapy
Phase phase 1
Sponsor MinYoung Kim, M.D.
Start date June 2013
End date December 2015
Trial size 5 participants
Trial identifier NCT01884155, UCBStroke

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Allogeneic umbilical cord blood therapy
allogeneic umbilical cord blood therapy

Primary Outcomes

Measure
Changes in Balance
time frame: Baseline - 1 month - 3 months - 6 months - 12 months

Secondary Outcomes

Measure
Changes in Mobility
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Muscle strength and Spasticity
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Activities of Daily Living
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Function of Upper extremity
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Hand function
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Visual perception
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Cognition
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Language
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Sensory function
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Brain structure
time frame: Baseline - 12 months
Changes in Brain glucose metabolism
time frame: Baseline - 12 months
Changes in Neural activity
time frame: Baseline - 6 months - 12 months
Monitoring Adverse Events
time frame: Baseline - 1 month - 3 months - 6 months - 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke
Principal investigator MinYoung Kim, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Bundang CHA Hospital.