StrokePhase 1NCT01884155
Allogeneic Umbilical Cord Blood Therapy for Stroke
A Phase 1 study testing Allogeneic umbilical cord blood therapy in people with Stroke, run by MinYoung Kim, M.D. at 1 site in South Korea.
Trial summary
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Allogeneic umbilical cord blood therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Allogeneic umbilical cord blood therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord blood therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic umbilical cord blood therapy | Experimental | Allogeneic umbilical cord blood therapy Receives: Procedure: Allogeneic umbilical cord blood therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Balance
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Secondary outcomes (13)
Changes in Mobility
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Muscle strength and Spasticity
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Activities of Daily Living
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Function of Upper extremity
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Hand function
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Visual perception
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Cognition
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Language
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Sensory function
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Brain structure
Measured: Baseline - 12 months
Changes in Brain glucose metabolism
Measured: Baseline - 12 months
Changes in Neural activity
Measured: Baseline - 6 months - 12 months
Monitoring Adverse Events
Measured: Baseline - 1 month - 3 months - 6 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- allogeneic cord blood for stroke patients
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MinYoung Kim, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MinYoung Kim, M.D., Bundang CHA Hospital
- Investigators
- MinYoung Kim, M.D., Ph.D., Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884155
- Sponsor's protocol ID
- UCBStroke
- Status last verified
- Oct 2017
- First submitted
- 19 Jun 2013
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Patients With Stroke
- ClinicalTrials.gov ID
- NCT01884155
- Acronym / sponsor ID
- UCBStroke
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MinYoung Kim, M.D.University, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with stroke.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- allogeneic cord blood for stroke patients
| Arm | Type | Receives |
|---|---|---|
| Allogeneic umbilical cord blood therapy | Experimental | Procedure: Allogeneic umbilical cord blood therapyAllogeneic umbilical cord blood therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic umbilical cord blood therapy | Procedure or surgery | Allogeneic umbilical cord blood therapy |
Primary outcome
Changes in Balance
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
13 secondary outcomes
Changes in Mobility
Time frame: 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
Changes in Activities of Daily Living
Time frame: 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
Changes in Hand function
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Visual perception
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Cognition
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Language
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Sensory function
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in Brain structure
Time frame: Baseline - 12 months
Changes in Brain glucose metabolism
Time frame: Baseline - 12 months
Changes in Neural activity
Time frame: Baseline - 6 months - 12 months
Monitoring Adverse Events
Time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
Related trials for Stroke
Recruiting
The AHA Oneida Study
Oneida Nation Members
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Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
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A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MinYoung Kim, M.D., Ph.D. principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic umbilical cord blood therapy in people with Stroke, run by MinYoung Kim, M.D. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Balance (time frame: Baseline - 1 month - 3 months - 6 months - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.