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Allogeneic Umbilical Cord Blood Therapy for Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01884155
First received: June 19, 2013
Last updated: January 8, 2014
Last verified: January 2014

June 19, 2013
January 8, 2014
June 2013
December 2015   (final data collection date for primary outcome measure)
Changes in Balance [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01884155 on ClinicalTrials.gov Archive Site
  • Changes in Mobility [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Muscle strength and Spasticity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Activities of Daily Living [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Function of Upper extremity [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Hand function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Visual perception [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Cognition [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Language [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Sensory function [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Changes in Brain structure [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
  • Changes in Brain glucose metabolism [ Time Frame: Baseline - 12 months ] [ Designated as safety issue: No ]
  • Changes in Neural activity [ Time Frame: Baseline - 6 months - 12 months ] [ Designated as safety issue: No ]
  • Monitoring Adverse Events [ Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Allogeneic Umbilical Cord Blood Therapy for Stroke
Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
Procedure: Allogeneic umbilical cord blood therapy
Experimental: Allogeneic umbilical cord blood therapy
Allogeneic umbilical cord blood therapy
Intervention: Procedure: Allogeneic umbilical cord blood therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01884155
UCBStroke
No
MinYoung Kim, M.D., Bundang CHA Hospital
MinYoung Kim, M.D.
Not Provided
Principal Investigator: MinYoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP