StrokeNCT01249287
FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients
An observational study of Stroke, run by China Medical University Hospital.
Trial summary
A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to not given
- Phase
- Observational
- 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
Study population: University hospital
Who may be able to join
- Old stroke half an year ~3 year
- One-sided MCA infarction
- NIHSS stroke scale: 9-20
Who cannot join
- Pacemaker
- Cerebral aneurysm clips
- Neurostimulator
- Metallic heart valves
- IUD
- Joint replacement
Show all 27Show fewer
- Metal plates
- Bone or joint pins
- Vena cava filters
- Embolization coils
- Cochlear implants
- Greenfieid filer
- Seizures
- Claustrophobia
- Bullet/gunshot
- Prosthesis (non-removeable)
- Artificial limbs (non-removeable)
- Surgical slips
- Metal screws or pins>
- Shrapnel/metallic fragments
- Harrington rod
- Insulin pump
- Ever had metal removed from in or around the eye
- Ever been metal worker (i.e., welder, machinist)
- Non-removeable hearing aids
- Birdnest or Gianturco filter
- Pregnant
About this study
A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. In this study, the investigators will test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination of corticospinal tract in the lesion side, focal increased perfusion and increased cortical activity in the peri-infarcted area will be monitored by the functional MRI after stem cell therapy. The investigators study is aimed to find the potential mechanisms of the functional recovery after stem cell implantation. The investigators also hope to find image surrogate markers for prediction of patient outcome. The possible surrogate markers will be helpful in improving the treatment procedure and patient selection.
- Conditions
- Stroke
- Keywords
- stroke, stem cell
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startApr 2009
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249287
- Sponsor's protocol ID
- DMR98-IRB-031
- Status last verified
- Nov 2010
- First submitted
- 25 Nov 2010
- Last updated
- 29 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT01249287
- Acronym / sponsor ID
- DMR98-IRB-031
- Conditions
- Stroke
- Keywords
- stroke, stem cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- First posted
- 29 Nov 2010 (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.
A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. In this study, the investigators will test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination of corticospinal tract in the lesion side, focal increased perfusion and increased cortical activity in the peri-infarcted area will be monitored by the functional MRI after stem cell therapy. The investigators study is aimed to find the potential mechanisms of the functional recovery after stem cell implantation. The investigators also hope to find image surrogate markers for prediction of patient outcome. The possible surrogate markers will be helpful in improving the treatment procedure and patient selection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospital
Key inclusion criteria (3 listed)
- Old stroke half an year ~3 year
- One-sided MCA infarction
- NIHSS stroke scale: 9-20
Key exclusion criteria (27 listed)
- Pacemaker
- Cerebral aneurysm clips
- Neurostimulator
- Metallic heart valves
- IUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by China Medical University Hospital.
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 3 inclusion and 27 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 29 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 29 Nov 2010.