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Completed

NCT Number: NCT01884155

Allogeneic Umbilical Cord Blood Therapy for Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic umbilical cord blood therapy

Procedure

Primary outcomes

  1. Changes in Balance

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

Secondary outcomes

  1. Changes in Mobility

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  2. Changes in Muscle strength and Spasticity

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  3. Changes in Activities of Daily Living

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  4. Changes in Function of Upper extremity

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  5. Changes in Hand function

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  6. Changes in Visual perception

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  7. Changes in Cognition

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  8. Changes in Language

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  9. Changes in Sensory function

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

  10. Changes in Brain structure

    Time frame: Baseline - 12 months

  11. Changes in Brain glucose metabolism

    Time frame: Baseline - 12 months

  12. Changes in Neural activity

    Time frame: Baseline - 6 months - 12 months

  13. Monitoring Adverse Events

    Time frame: Baseline - 1 month - 3 months - 6 months - 12 months

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2013
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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