Alzheimer's DiseasePhase 2RNAScNCT00927108
Rajavtihi Neuronal Adult Stem Cells Project
A Phase 2 study testing Progenitor Stem Cell Culture in people with Alzheimer's Disease and Parkinson's Disease, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To study the success of Oligodendrocyte progenitor cell culture project in Rajavithi Hospital to identify an unlimited clone human neuronal progenitor stem cells from the human brain in the Biomolecular Research Center. Read more about this study
- Who is it for?
- Ages 20 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis
- What is being tested?
- Progenitor Stem Cell Culture
- How many people
- 0 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2009to Dec 2011
- 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 20 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have elective craniotomy or.
- Patients who have elective ventriculostomy surgery or.
- Patients who have elective muscle biopsy or nerve biopsy.
- Patient who have emergency craniectomy for life threatening from emergency medical and surgical conditions such as Brain herniation or head injury
Who cannot join
- Central nervous system infection for example tuberculous or any bacterial infection, Viral infection, fungal infection.
- Central nervous system Tumor, Malignancy and metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adult Neuronal Progenitor Stem Cell Project
To study the success of Oligodendrocyte progenitor cell culture project in Rajavithi Hospital to identify an unlimited clone human neuronal progenitor stem cells from the human brain in the Biomolecular Research Center. This study aims to produce the reproductive clone of neuronal development protocols and advance projects. Neuronal cells such as pyramidal cells, oligodendrocyte, and dopaminergic neuron differentiation protocol/projects for treatment of Alzheimer's disease, Multiple sclerosis, and Parkinson's disease respectively in next phase of clinical trials.
- Conditions
- Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis
- Being tested
- Progenitor Stem Cell Culture
- Keywords
- Adult Progenitor Stem cells, Alzheimer's disease, Parkinson's disease, Multiple sclerosis
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progenitor Stem Cell CultureOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Cell culture
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Rajavithi Biomolecular Research Center
- Responsible party
- Sponsor
- Investigators
- Subsai Kongsaengdao, M.D., Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927108
- Sponsor's protocol ID
- RH-CMR-005
- Acronym
- RNASc
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2009
- 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
- Adult Neuronal Progenitor Stem Cell Project
- ClinicalTrials.gov ID
- NCT00927108
- Acronym / sponsor ID
- RNASc / RH-CMR-005
- Conditions
- Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis
- Keywords
- Adult Progenitor Stem cells, Alzheimer's disease, Parkinson's disease, Multiple sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Rajavithi Biomolecular Research Center
- Study start
- Jul 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Jun 2009 (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.
To study the success of Oligodendrocyte progenitor cell culture project in Rajavithi Hospital to identify an unlimited clone human neuronal progenitor stem cells from the human brain in the Biomolecular Research Center. This study aims to produce the reproductive clone of neuronal development protocols and advance projects. Neuronal cells such as pyramidal cells, oligodendrocyte, and dopaminergic neuron differentiation protocol/projects for treatment of Alzheimer's disease, Multiple sclerosis, and Parkinson's disease respectively in next phase of clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Cell culture
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have elective craniotomy or.
- Patients who have elective ventriculostomy surgery or.
- Patients who have elective muscle biopsy or nerve biopsy.
- Patient who have emergency craniectomy for life threatening from emergency medical and surgical conditions such as Brain herniation or head injury
Key exclusion criteria (2 listed)
- Central nervous system infection for example tuberculous or any bacterial infection, Viral infection, fungal infection.
- Central nervous system Tumor, Malignancy and metastasis.
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 |
|---|---|---|
| Progenitor Stem Cell Culture | Other | – |
Primary outcome
Not reported in the source record.
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 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
Department of Medical Services Ministry of Public Health of Thailand
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 Progenitor Stem Cell Culture in people with Alzheimer's Disease and Parkinson's Disease, 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 4 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: withdrawn, 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 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.
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.