Infarction, Middle Cerebral ArteryPhase 1OECsNCT01327768
Implantation of Olfactory Ensheathing Cells (OECs)
A Phase 1 study testing Olfactory ensheathing cells in people with Infarction, Middle Cerebral Artery and Ischemic Stroke,, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,
- What is being tested?
- Olfactory ensheathing cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to May 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 35-70 year old Chronic Stroke Adult Patients,
- With Stroke History of More Than 6 Months, Less Than 60 Months,
- With Stable Hemiplegia Condition,
- NIHSS Score Is Between 5~15.
Who cannot join
- Patients Aged Less Than 35 or More Than 70,
- Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory,
- NIHSS Is Not In The Range of 5~15,
- Pregnant Women,
- Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital, Center of Neuropsychiatry
Taichung, 40447
Hsiao-Jung Wang, M.S., 886-4-22052121 ext. 7812, city6364@yahoo.com
Woei-Cherng Shyu, M.D., Ph.D
About this study
Official title: Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain.
Read the detailed description
(1)Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplanted the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain. (2) Combination with traditional drug therapy (such as used the anti-thrombosis reagent or anti-platelet aggregation reagent). (3) NIH-stroke scale (NIHSS), European stroke scale (ESS), European stroke motor subscale (EMS), Barthel Index(BI) and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points. (4) In addition, MRI(DTI) \& TMS(MEP) will be also checked for each recruitment patient as the secondary end points.
- Conditions
- Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,, Thromboembolic Stroke.
- Being tested
- Olfactory ensheathing cells
- Keywords
- Stroke,, Stem Cell,, Olfactory Ensheathing Cells,, Intracerebral Implantation of Olfactory Ensheathing Cells.
- Medical subject headings
- Infarction, Middle Cerebral Artery, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory ensheathing cellsProcedure or surgery
Also called Stroke,, Stem Cells,, Olfactory Ensheathing Cells,, Early Phase Clinical Trial.
Recruited patients should be received the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Finally, we will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain for old stroke ischemic patients.
| Study group | Role | What they receive |
|---|---|---|
| OECs, Medicine, Rehabilitation | Experimental | Stroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation. Receives: Procedure: Olfactory ensheathing cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-Stroke Scale
National Institute of Health-Stroke Scale will be performed to evaluate including muscle power of hemiparetic limbs, sensory function and flurency of speech of each patient to document the therapeutic effect.
Measured: within 1 year after surgery
Secondary outcomes (2)
MRI(DTI)
Magnetic Resonance Image (Diffusion Tensor Image) will be performed to evaluate the increase of the number of fiber tracts (pyramidal tract) in the stroke brain of each patient to document the therapeutic effect.
Measured: within 1 year after surgery
TMS(MEP)
Trans-cranial Magnetic Stimulation (Motor Evoked Potential) will be performed to evaluate the electrophysiological response of stroke brain of each patient to document the therapeutic effect.
Measured: within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infarction, Middle Cerebral ArteryStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Woei-Cherng Shyu, M.D., Ph.D, Study chair, shyu9423@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327768
- Sponsor's protocol ID
- CN1U00-1
- Acronym
- OECs
- Status last verified
- Sep 2011
- First submitted
- 31 Jan 2011
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Feasibility and Treatment Potential for Old Stroke Patients Using Intracerebral Implantation of Olfactory Ensheathing Cells
- ClinicalTrials.gov ID
- NCT01327768
- Acronym / sponsor ID
- OECs / CN1U00-1
- Conditions
- Infarction, Middle Cerebral Artery, Ischemic Stroke,, Stroke With Hemiparesis,, Thromboembolic Stroke.
- Keywords
- Stroke,, Stem Cell,, Olfactory Ensheathing Cells,, Intracerebral Implantation of Olfactory Ensheathing Cells.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 4 Apr 2011 (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.
Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain.
Detailed description
(1)Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplanted the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain. (2) Combination with traditional drug therapy (such as used the anti-thrombosis reagent or anti-platelet aggregation reagent). (3) NIH-stroke scale (NIHSS), European stroke scale (ESS), European stroke motor subscale (EMS), Barthel Index(BI) and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points. (4) In addition, MRI(DTI) \& TMS(MEP) will be also checked for each recruitment patient as the secondary end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OECs, Medicine, Rehabilitation | Experimental | Procedure: Olfactory ensheathing cellsStroke patients are received intracerebral implantation of Olfactory ensheathing cells(OECs), Antiplatelet Medication, and Rehabilitation. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 35-70 year old Chronic Stroke Adult Patients,
- With Stroke History of More Than 6 Months, Less Than 60 Months,
- With Stable Hemiplegia Condition,
- NIHSS Score Is Between 5~15.
Key exclusion criteria (5 listed)
- Patients Aged Less Than 35 or More Than 70,
- Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory,
- NIHSS Is Not In The Range of 5~15,
- Pregnant Women,
- Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.
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 |
|---|---|---|
| Olfactory ensheathing cellsAlso: Stroke,, Stem Cells,, Olfactory Ensheathing Cells,, Early Phase Clinical Trial.Recruited patients should be received the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Finally, we will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain for old stroke ischemic patients. | Procedure or surgery | OECs, Medicine, Rehabilitation |
Primary outcome
NIH-Stroke Scale
Time frame: within 1 year after surgery
National Institute of Health-Stroke Scale will be performed to evaluate including muscle power of hemiparetic limbs, sensory function and flurency of speech of each patient to document the therapeutic effect.
2 secondary outcomes
MRI(DTI)
Time frame: within 1 year after surgery
TMS(MEP)
Time frame: within 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
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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.
Woei-Cherng Shyu, M.D., Ph.D study chair
shyu9423@gmail.com
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 Olfactory ensheathing cells in people with Infarction, Middle Cerebral Artery and Ischemic Stroke,, run by China Medical University Hospital at 1 site in Taiwan.
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 3 Oct 2011. 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 Taiwan. 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?
Contact Hsiao-Jung Wang, M.S. (886-4-22052121 ext. 7812, city6364@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH-Stroke Scale (time frame: within 1 year after surgery). 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 3 Oct 2011.