- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01884155
Allogeneic Umbilical Cord Blood Therapy for Stroke
October 10, 2017 updated by: MinYoung Kim, M.D.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Allogeneic umbilical cord blood therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Balance
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Mobility
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Muscle strength and Spasticity
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Activities of Daily Living
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Function of Upper extremity
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Hand function
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Visual perception
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Cognition
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Language
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Sensory function
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Changes in Brain structure
Time Frame: Baseline - 12 months
|
Baseline - 12 months
|
Changes in Brain glucose metabolism
Time Frame: Baseline - 12 months
|
Baseline - 12 months
|
Changes in Neural activity
Time Frame: Baseline - 6 months - 12 months
|
Baseline - 6 months - 12 months
|
Monitoring Adverse Events
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
|
Baseline - 1 month - 3 months - 6 months - 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
June 19, 2013
First Submitted That Met QC Criteria
June 20, 2013
First Posted (ESTIMATE)
June 21, 2013
Study Record Updates
Last Update Posted (ACTUAL)
October 12, 2017
Last Update Submitted That Met QC Criteria
October 10, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCBStroke
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Allogeneic umbilical cord blood therapy
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MinYoung Kim, M.D.CHA UniversityCompleted
-
Bundang CHA HospitalWithdrawn
-
MinYoung Kim, M.D.CHA UniversityCompletedGlobal Developmental DelayKorea, Republic of
-
BHI Therapeutic SciencesUnknownAcute Ischemic StrokeUnited States
-
MinYoung Kim, M.D.Completed
-
Joanne Kurtzberg, MDThe Marcus FoundationCompleted
-
Guangdong Women and Children HospitalUnknownSafety Issues | Effect of DrugsChina
-
Guangdong Women and Children HospitalRecruitingSafety Issues;Effect of DrugsChina
-
Pomeranian Medical University SzczecinUnknownNecrotizing Enterocolitis | Intracranial Hemorrhages | Retinopathy of Prematurity | Respiratory Distress Syndrome, Newborn | Anemia, Neonatal | Bronchopulmonary DysplasiaPoland