Stroke Clinical Trial
Official title:
Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
Verified date | January 2018 |
Source | China Spinal Cord Injury Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | July 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong | |
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
China Spinal Cord Injury Network | Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, StemCyte, Inc., The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. | Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. | 18 months, up to 36 months follow-up | |
Primary | National Institutes of Health Stroke Scale | The change from the baseline in National Institutes of Health Stroke Scales | 18 months, up to 36 months | |
Secondary | European Stroke Scale (ESS) | The change from baseline in ESS | 18 months, up to 36 months if applicable | |
Secondary | Barthel Index | 18 months | ||
Secondary | Min-Mental State Examination (MMSE) | The change from baseline in MMSE | 18 months | |
Secondary | MRI | The change in MRI between pre-treatment and post-treatment | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |