NCT01884155

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Jun 2013

Typical duration for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

June 19, 2013

Last Update Submit

October 10, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Changes in Balance

    Baseline - 1 month - 3 months - 6 months - 12 months

Secondary Outcomes (13)

  • Changes in Mobility

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Muscle strength and Spasticity

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Activities of Daily Living

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Function of Upper extremity

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Hand function

    Baseline - 1 month - 3 months - 6 months - 12 months

  • +8 more secondary outcomes

Study Arms (1)

Allogeneic umbilical cord blood therapy

EXPERIMENTAL

Allogeneic umbilical cord blood therapy

Procedure: Allogeneic umbilical cord blood therapy

Interventions

Allogeneic umbilical cord blood therapyPROCEDURE
Allogeneic umbilical cord blood therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

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

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • MinYoung Kim, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: allogeneic cord blood for stroke patients
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

KR(1)