- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283879
Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- The Fifth Affiliated Hospital Immunotherapy center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
|
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of infarct size measured by brain MRI
Time Frame: before the transplant and 1, 6, 12 months after transplantation
|
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
|
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
|
before the transplant and after the transplant 1, 2 and 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ping J Chen, Professor, The Fifth Affiliated Hospital of Guangzhou Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYK-Cerebral hemorrhage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Cerebral Hemorrhage
-
Penumbra Inc.Active, not recruitingCerebral Hemorrhage | Intracerebral Hemorrhage | Brain Hemorrhage | Cerebral Parenchymal HemorrhageUnited States, Germany, Canada, Austria
-
University of Maryland, BaltimoreRecruitingIntra Cerebral Hemorrhage | Subarachnoid Hemorrhage | Intraventricular Hemorrhage | Nontraumatic HaemorrhageUnited States
-
El Instituto Nacional de Neurologia y Neurocirugia...CompletedBrain Ischemia | Subarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Delayed Cerebral Ischemia | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralMexico
-
Hackensack Meridian HealthRecruitingStroke | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Cerebral Aneurysm | Cerebral Ischemia | Vasospasm, CerebralUnited States
-
Tang-Du HospitalRecruitingSpontaneous Intracranial Hemorrhage | Spontaneous Intraparenchymal Cerebral Hemorrhage | Spontaneous Cerebellar HaemorrhageChina
-
Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS); Pitié-Salpêtrière...RecruitingIntra Cerebral HemorrhageUnited States
-
National Taiwan University HospitalCompletedIntra Cerebral HemorrhageTaiwan
-
Medical University of ViennaUniversity of Vienna; Austrian Science Fund (FWF)RecruitingSubarachnoid Hemorrhage, Aneurysmal | Delayed Cerebral Ischemia | Vasospasm, CerebralAustria
-
Montefiore Medical CenterRecruitingSubarachnoid Hemorrhage | Intracerebral Hemorrhage | Hydrocephalus | Ventriculitis, CerebralUnited States
Clinical Trials on Human umbilical cord mesenchymal stem cells
-
Limin RongCompleted
-
Shenzhen Beike Bio-Technology Co., Ltd.The Second Affiliated Hospital of Kunming Medical UniversityUnknown
-
Central South UniversityUnknown
-
Asia Cell Therapeutics (Shanghai) Co., Ltd.Not yet recruitingAcute Respiratory Distress Syndrome
-
Shanghai General Hospital, Shanghai Jiao Tong University...RecruitingLumbar Disc Herniation | Lumbar Disc DegenerationChina
-
Yan'an Affiliated Hospital of Kunming Medical UniversityRecruitingDiabetic Nephropathy | Mesenchymal Stem CellsChina
-
Affiliated Hospital to Academy of Military Medical...Unknown
-
Shenzhen Beike Bio-Technology Co., Ltd.The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical... and other collaboratorsUnknownProgressive Multiple Sclerosis | Neuromyelitis Optica.China
-
Asia Cell Therapeutics (Shanghai) Co., Ltd.Not yet recruitingDecompensated Liver Cirrhosis
-
Southwest Hospital, ChinaNot yet recruiting