Allogeneic Umbilical Cord Blood Therapy for Stroke

Stroke Clinical Trial

Official title:

Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884155
• Other study ID #: UCBStroke
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2013
• Last updated: October 10, 2017
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Allogeneic umbilical cord blood therapy

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
MinYoung Kim, M.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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