Demyelinating DiseasesPhase 1NCT00283023
Oligodendrocyte Progenitor Cell Culture From Human Brain
A Phase 1 study testing Oligodendrocyte progenitor cell culture/craniotomy in people with Demyelinating Diseases, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Demyelinating Diseases
- What is being tested?
- Oligodendrocyte progenitor cell culture/craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2007to Dec 2010
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 20-65 years of age
- Informed consent
- Has elective craniotomy surgery
Who cannot join
- HIV, hepatitis, and other central nervous system (CNS) infections
- Dementia, Alzheimer disease, and neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1: Oligodendrocyte Progenitor Cell Culture From Human Brain
Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.
Read the detailed description
Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis.
- Conditions
- Demyelinating Diseases
- Being tested
- Oligodendrocyte progenitor cell culture/craniotomy
- Keywords
- All selective craniotomy
- Medical subject headings
- Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligodendrocyte progenitor cell culture/craniotomyProcedure or surgery
Also called Rajavithi Oligodendrocyte progenitor cell culture protocol
Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Progenitor cells from the patinets with Craniotomy with V-P Shunt or ventriculostomy will be collected and cultured. Receives: Procedure: Oligodendrocyte progenitor cell culture/craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oligodendrocyte progenitor cell differentiation
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demyelinating DiseasesStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cell culture
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Investigators
- Subsai Kongsaengdao, M.D., Principal investigator, Division of Neurology, Department of Medicine, Rajavithi Hospital : Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283023
- Sponsor's protocol ID
- RH-CMR-003
- Other IDs
- RVH-CMR-003 grant
- Status last verified
- Oct 2020
- First submitted
- 25 Jan 2006
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1: Oligodendrocyte Progenitor Cell Culture From Human Brain
- ClinicalTrials.gov ID
- NCT00283023
- Acronym / sponsor ID
- RH-CMR-003
- Conditions
- Demyelinating Diseases
- Keywords
- All selective craniotomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- Dec 2007 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2006 (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.
Recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. Clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. The researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.
Detailed description
Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with Multiple sclerosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cell culture
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Oligodendrocyte progenitor cell culture/craniotomyProgenitor cells from the patinets with Craniotomy with V-P Shunt or ventriculostomy will be collected and cultured. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 20-65 years of age
- Informed consent
- Has elective craniotomy surgery
Key exclusion criteria (2 listed)
- HIV, hepatitis, and other central nervous system (CNS) infections
- Dementia, Alzheimer disease, and neurodegenerative disease
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 |
|---|---|---|
| Oligodendrocyte progenitor cell culture/craniotomyAlso: Rajavithi Oligodendrocyte progenitor cell culture protocolOligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply | Procedure or surgery | A |
Primary outcome
Number of oligodendrocyte progenitor cell differentiation
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Subsai Kongsaengdao, M.D. principal investigator
Division of Neurology, Department of Medicine, Rajavithi Hospital : Thailand
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 Oligodendrocyte progenitor cell culture/craniotomy in people with Demyelinating Diseases, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 19 Oct 2020. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of oligodendrocyte progenitor cell differentiation (time frame: one month). 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 19 Oct 2020.