StrokePhase 2NCT01389453

The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

A Phase 2 study testing stem cell transplantation in people with Stroke, run by General Hospital of Chinese Armed Police Forces at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Stroke
What is being tested?: stem cell transplantation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: Apr 2011to Dec 2012
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All tested patients with cerebral infarction, cerebral hemorrhage must tally with the diagnosis standard which in 1995 the Chinese fourth session of brain blood vessel of academic conference formulated, and after the head CT, MRI confirmation. All patients should be taken bad completely within for 24 hours.
patient's age and gender: 40-65years，the gender is not limit;
the hemorrhage, block region：One side basis festival area, one side brain stem;
the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms.

Who cannot join

Progressive apoplexy;
other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
the patient with tumor in every system on there body;
Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel).

Trial locations and contacts

1 site in 1 country.

China1 site

Yihua An
Beijing, Beijing Municipality, 100039

Other trials in China

About this study

Official title: Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction

All experimental group patients of 100 patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation. The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Read the detailed description

The control group of 20 patients accept injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Conditions: Stroke
Being tested: stem cell transplantation
Keywords: umbilical cord mesenchyma stem cell transplantation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stem cell transplantationProcedure or surgery
Also called umbilical cord mesenchyma stem cell transplantation
Patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

Study groups in NCT01389453
Study group	Role	What they receive
stem cell transplatation	Active comparator	All experimental group patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation. Receives: Procedure: stem cell transplantation
control	No intervention	The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

What is being measured

The primary outcome is the main question the study is designed to answer.

NIHSS and FIM
All patients should receive the American State-run Health Research institute apoplexy meter (NIHSS)evaluation, the Fugl-Meyer evaluation, the function independence evaluation (FIM) separately before the transplant and after the transplant 1, 2 and 3 months , and the grading has the distinct improvement;
Measured: before the transplant and after the transplant 1, 2 and 3 months

Secondary outcomes (2)

Motor evoked potential and sensation evoked potential inspection
All patients should be receive Motor evoked potential and sensation evoked potential inspection separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months, and the function of movement and sensation get obvious improvement;
Measured: before the transplant and after the transplant 0, 1, 3, 6 and 12 months
MRI+ DWI+ enhancement scanning
All patients should be receive cranial MRI+ DWI+ enhancement scanning separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months, and the result tells us that there is obvious blood vessel proliferation on the surrounding of damaged region;
Measured: before the transplant and after the transplant 0, 1, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2012

First posted8 Jul 2011 (estimated)
Study startApr 2011
Primary completionDec 2011 (estimated)
Study completionDec 2012 (estimated)

Why it stopped: There were not enough number of patients recruited till DEC 31th in 2012.

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.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01389453
Sponsor's protocol ID: 2011-04-17 stroke
Status last verified: Oct 2011
First submitted: 6 Jul 2011
Last updated: 28 Feb 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction
ClinicalTrials.gov ID: NCT01389453
Acronym / sponsor ID: 2011-04-17 stroke
Conditions: Stroke
Keywords: umbilical cord mesenchyma stem cell transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: There were not enough number of patients recruited till DEC 31th in 2012.
Enrolment: 0 participants (actual)
Lead sponsor: General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
Study start: Apr 2011
Primary completion: Dec 2011 (estimated)
Study completion: Dec 2012 (estimated)
First posted: 8 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
stem cell transplatation	Active comparator	Procedure: stem cell transplantationAll experimental group patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.
control	No intervention	–The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

All tested patients with cerebral infarction, cerebral hemorrhage must tally with the diagnosis standard which in 1995 the Chinese fourth session of brain blood vessel of academic conference formulated, and after the head CT, MRI confirmation. All patients should be taken bad completely within for 24 hours.
patient's age and gender: 40-65years，the gender is not limit;
the hemorrhage, block region：One side basis festival area, one side brain stem;
the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms.

Key exclusion criteria (5 listed)

Progressive apoplexy;
other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
the patient with tumor in every system on there body;
Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel).

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
stem cell transplantationAlso: umbilical cord mesenchyma stem cell transplantationPatients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.	Procedure or surgery	stem cell transplatation

Primary outcome

NIHSS and FIM
Time frame: before the transplant and after the transplant 1, 2 and 3 months
All patients should receive the American State-run Health Research institute apoplexy meter (NIHSS)evaluation, the Fugl-Meyer evaluation, the function independence evaluation (FIM) separately before the transplant and after the transplant 1, 2 and 3 months , and the grading has the distinct improvement;

2 secondary outcomes

Motor evoked potential and sensation evoked potential inspection
Time frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months
MRI+ DWI+ enhancement scanning
Time frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

An Yihua, doctor study director

Chinese People's Armed Police Force

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing stem cell transplantation in people with Stroke, run by General Hospital of Chinese Armed Police Forces 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: withdrawn, as of the sponsor's last update on 28 Feb 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

NIHSS and FIM (time frame: before the transplant and after the transplant 1, 2 and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01389453.

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 28 Feb 2013.