Cerebral HemorrhagePhase 1NCT02283879
Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
A Phase 1 study testing Human umbilical cord mesenchymal stem cells in people with Cerebral Hemorrhage, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Apr 2017
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-70 intracerebral hemorrhage patient
- With stroke history of more than 3 months, less than 60 months
- National Institutes of Health stroke scale(NIHSS) score of 7 or more points
- Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)
Who cannot join
- History of neurological disease, head injury or psychiatric disorder;
- Pregnant women;
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- Progressive apoplexy;
- With malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital Immunotherapy center
Guangzhou, Guangdong, 510000
About this study
Official title: Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
Read the detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.
To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.
- Conditions
- Cerebral Hemorrhage
- Being tested
- Human umbilical cord mesenchymal stem cells
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Cerebral hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cellsBiological
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. Receives: Biological: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Measured: 12 months
Secondary outcomes (3)
Improvement of infarct size measured by brain MRI
Measured: before the transplant and 1, 6, 12 months after transplantation
Modified Barthel index
Measured: before and 1, 3, 6 and 12 months after transplantation
National Institutes of Health stroke scale(NIHSS) score
Measured: before the transplant and after the transplant 1, 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Ping J Chen, Professor, Principal investigator, Fifth Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283879
- Sponsor's protocol ID
- HYK-Cerebral hemorrhage
- Status last verified
- Jul 2015
- First submitted
- 3 Nov 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02283879
- Acronym / sponsor ID
- HYK-Cerebral hemorrhage
- Conditions
- Cerebral Hemorrhage
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Cerebral hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 5 Nov 2014 (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 purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.
Detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.
To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hUC-MSC treatment | Experimental | Biological: Human umbilical cord mesenchymal stem cellsPatients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 40-70 intracerebral hemorrhage patient
- With stroke history of more than 3 months, less than 60 months
- National Institutes of Health stroke scale(NIHSS) score of 7 or more points
- Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)
Key exclusion criteria (5 listed)
- History of neurological disease, head injury or psychiatric disorder;
- Pregnant women;
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- Progressive apoplexy;
- With malignant tumors.
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cellsA single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. | Biological | hUC-MSC treatment |
Primary outcome
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Time frame: 12 months
3 secondary outcomes
Improvement of infarct size measured by brain MRI
Time frame: before the transplant and 1, 6, 12 months after transplantation
Modified Barthel index
Time frame: before and 1, 3, 6 and 12 months after transplantation
National Institutes of Health stroke scale(NIHSS) score
Time frame: before the transplant and after the transplant 1, 2 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: Undecided
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
Ping J Chen, Professor principal investigator
Fifth Affiliated Hospital of Guangzhou Medical 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 Human umbilical cord mesenchymal stem cells in people with Cerebral Hemorrhage, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
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 5 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 24 May 2016. 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 China. 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?
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?
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs) (time frame: 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 24 May 2016.