NCT01673932

Brief Summary

The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

6.2 years

First QC Date

August 24, 2012

Last Update Submit

January 29, 2018

Conditions

StrokeIschemic StrokeBrain Ischemia

Keywords

strokechronic strokeischemic strokeumbilical cord bloodmononuclear celltransplant

Outcome Measures

Primary Outcomes (1)

  • National Institutes of Health Stroke Scale

    The change from the baseline in National Institutes of Health Stroke Scales

    18 months, up to 36 months

Secondary Outcomes (4)

  • European Stroke Scale (ESS)

    18 months, up to 36 months if applicable

  • Barthel Index

    18 months

  • Min-Mental State Examination (MMSE)

    18 months

  • MRI

    18 months

Other Outcomes (1)

  • Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.

    18 months, up to 36 months follow-up

Study Arms (2)

Group A - UCBMC Early Treatment Group

EXPERIMENTAL

Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.

Biological: UCBMCProcedure: surgery

Group B - UCBMC Delayed Treatment Group

EXPERIMENTAL

Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.

Biological: UCBMCProcedure: surgery

Interventions

UCBMCBIOLOGICAL

Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site

Group A - UCBMC Early Treatment GroupGroup B - UCBMC Delayed Treatment Group
surgeryPROCEDURE
Group A - UCBMC Early Treatment GroupGroup B - UCBMC Delayed Treatment Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • either gender, age 35 -65 years old;
  • ischemic stroke \> 6 months and \< 60 months;
  • stable hemiplegia or hemiparesis condition \> 3 months;
  • stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;
  • stroke in the middle cerebral artery territory;
  • subjects able to understand, sign and date the informed consent form

You may not qualify if:

  • non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;
  • pregnant or lactating women;
  • alcohol or drug abuse in previous 3 months;
  • significant medical diseases or infections;
  • current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;
  • unavailability of HLA-matched umbilical cord blood unit;
  • investigator suggests that the subject would not suitable to perform the surgery or participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

StrokeIschemic StrokeBrain Ischemia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Waisang Poon, MD

    The Chinese University of Hong Kong, Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

  • Gilberto Ka Kit Leung, MD

    The University of Hong Kong, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2012

First Posted

August 28, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2018

Study Completion

July 1, 2019

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

HK(2)