StrokePhase 1NCT01673932
Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
A Phase 1 study testing UCBMC and surgery in people with Stroke and Ischemic Stroke, run by China Spinal Cord Injury Network at 2 sites in Hong Kong.
Trial summary
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Ischemic Stroke, Brain Ischemia
- What is being tested?
- UCBMC and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesHong Kong
- Study dates
- Oct 2012to Jul 2019
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Karrie Kiang, +852 2255 4468, mykiang@hku.hk
Gilberto Ka Kit Leung, MD
- Recruiting
Prince of Wales Hospital
Shatin
Waisang Poon, MD, +852 2632 1625, stroke-study@surgery.cuhk.edu.hk
Waisang Poon, MD
About this study
Official title: Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.
Read the detailed description
This is an open-label, delayed-treatment trial.
A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
- Conditions
- Stroke, Ischemic Stroke, Brain Ischemia
- Being tested
- UCBMC, surgery
- Keywords
- stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant
- Medical subject headings
- Stroke, Ischemic Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCBMCBiological
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: UCBMC; Procedure: 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. Receives: Biological: UCBMC; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale
The change from the baseline in National Institutes of Health Stroke Scales
Measured: 18 months, up to 36 months
Secondary outcomes (4)
European Stroke Scale (ESS)
The change from baseline in ESS
Measured: 18 months, up to 36 months if applicable
Barthel Index
Measured: 18 months
Min-Mental State Examination (MMSE)
The change from baseline in MMSE
Measured: 18 months
MRI
The change in MRI between pre-treatment and post-treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Spinal Cord Injury Network
- Sponsor type
- Research network
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, StemCyte, Inc.
- Responsible party
- Sponsor
- Investigators
- Waisang Poon, MD, Principal investigator, The Chinese University of Hong Kong, Prince of Wales HospitalGilberto Ka Kit Leung, MD, Principal investigator, The University of Hong Kong, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673932
- Sponsor's protocol ID
- UCB-IS-01
- Status last verified
- Jan 2018
- First submitted
- 24 Aug 2012
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01673932
- Acronym / sponsor ID
- UCB-IS-01
- Conditions
- Stroke, Ischemic Stroke, Brain Ischemia
- Keywords
- stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- China Spinal Cord Injury NetworkResearch network
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, StemCyte, Inc.
- Study start
- Oct 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 28 Aug 2012 (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.
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.
Detailed description
This is an open-label, delayed-treatment trial.
A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - UCBMC Early Treatment Group | Experimental | Biological: UCBMC, Procedure: surgeryGroup A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. |
| Group B - UCBMC Delayed Treatment Group | Experimental | Biological: UCBMC, Procedure: surgeryGroup B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| UCBMCTransplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site | Biological | Group A - UCBMC Early Treatment Group, Group B - UCBMC Delayed Treatment Group |
| surgery | Procedure or surgery | Group A - UCBMC Early Treatment Group, Group B - UCBMC Delayed Treatment Group |
Primary outcome
National Institutes of Health Stroke Scale
Time frame: 18 months, up to 36 months
The change from the baseline in National Institutes of Health Stroke Scales
4 secondary outcomes
European Stroke Scale (ESS)
Time frame: 18 months, up to 36 months if applicable
Barthel Index
Time frame: 18 months
Min-Mental State Examination (MMSE)
Time frame: 18 months
MRI
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
Waisang Poon, MD principal investigator
The Chinese University of Hong Kong, Prince of Wales Hospital
Gilberto Ka Kit Leung, MD principal investigator
The University of Hong Kong, Queen Mary Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCBMC and surgery in people with Stroke and Ischemic Stroke, run by China Spinal Cord Injury Network at 2 sites in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale (time frame: 18 months, up to 36 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 31 Jan 2018.