Progressive Multiple SclerosisPhase 1/2NCT01364246
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells in people with Progressive Multiple Sclerosis and Neuromyelitis Optica., run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
Trial summary
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Progressive Multiple Sclerosis, Neuromyelitis Optica.
- What is being tested?
- human umbilical cord mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2014
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.
- Aged 16-65 years.
- Disease duration≥2years
- Poor response to steroid therapy.
- Written informed consent and follow the clinic trail procedure
Who cannot join
- Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.
- Combined Pneumonia or other Severe systemic bacteria infection.
- Severe drug allergic history or anaphylaxis to 2 or more food or medicine.
- Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/
- HIV+, TPPA +， patients diagnosed as HBV or HCV.
- Tumor Markers +
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- Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form.
- Coagulation disorders.
- Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg.
- Pregnancy.
- Enrollment in other trials in the last 3 months.
- Other criteria the investigator consider improper for inclusion.
Trial locations and contacts
1 site in 1 country.
Yun Yun Xu contact
China1 site, 1 recruiting
- Recruiting
Nanjing University Medical College Affiliated Drum Tower Hospital
Nanjing, Jiangsu
Yun Xu, xuyun20042001@yahoo.com.cn
About this study
Official title: Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.
Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.
- Being tested
- human umbilical cord mesenchymal stem cells
- Keywords
- Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsBiological
Participants will be given hUC-MSCs transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Human umbilical cord mesenchymal stem cells transplantation | Experimental | Intervention group Receives: Biological: human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Expanded Disability Status Scale (EDSS)
Measured: 1 year after treatment
Secondary outcomes (4)
Visual Evoked Potential (VEP)
Measured: 1 year after treatment
Brainstem Auditory Evoked Potential (BAEP)
Measured: 1 year after treatment
Somatosensory Evoked Potential(SEP)
Measured: 1 year after treatment
Brain Magnetic Resonance Imaging （MRI） Scan
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing Medical University, Nanjing University Medical College Affiliated Wuxi Second Hospital, Xuzhou Medical University, The Second Hospital of Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364246
- Sponsor's protocol ID
- BKCR-MS-1.0(2010)
- Status last verified
- Nov 2012
- First submitted
- 31 May 2011
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
- ClinicalTrials.gov ID
- NCT01364246
- Acronym / sponsor ID
- BKCR-MS-1.0(2010)
- Keywords
- Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing Medical University, Nanjing University Medical College Affiliated Wuxi Second Hospital, Xuzhou Medical University, The Second Hospital of Nanjing Medical University
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Jun 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.
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.
Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human umbilical cord mesenchymal stem cells transplantation | Experimental | Biological: human umbilical cord mesenchymal stem cellsIntervention group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.
- Aged 16-65 years.
- Disease duration≥2years
- Poor response to steroid therapy.
- Written informed consent and follow the clinic trail procedure
Key exclusion criteria (12 listed)
- Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.
- Combined Pneumonia or other Severe systemic bacteria infection.
- Severe drug allergic history or anaphylaxis to 2 or more food or medicine.
- Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/
- HIV+, TPPA +， patients diagnosed as HBV or HCV.
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 |
|---|---|---|
| human umbilical cord mesenchymal stem cellsParticipants will be given hUC-MSCs transplantation. | Biological | Human umbilical cord mesenchymal stem cells transplantation |
Primary outcome
Score of Expanded Disability Status Scale (EDSS)
Time frame: 1 year after treatment
4 secondary outcomes
Visual Evoked Potential (VEP)
Time frame: 1 year after treatment
Brainstem Auditory Evoked Potential (BAEP)
Time frame: 1 year after treatment
Somatosensory Evoked Potential(SEP)
Time frame: 1 year after treatment
Brain Magnetic Resonance Imaging （MRI） Scan
Time frame: 1 year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
Yun Yun Xu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells in people with Progressive Multiple Sclerosis and Neuromyelitis Optica., run by Shenzhen Beike Bio-Technology Co., Ltd. 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 5 inclusion and 12 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 28 Nov 2012. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Yun Xu (xuyun20042001@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Expanded Disability Status Scale (EDSS) (time frame: 1 year after treatment). 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 28 Nov 2012.