Parkinson's DiseaseNCT01329926
Molecular Analysis of Human Neural Stem Cells
An observational study of Parkinson's Disease and Parkinsonism, run by NeuroGeneration at 1 site in United States.
Trial summary
The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson's Disease, Parkinsonism
- What is being tested?
- Harvesting of neural stem cells
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2011to 31 Dec 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease or parkinsonism
Who may be able to join
- Able to give informed consent prior to study
- Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
- Age 35 to 85 years old
- Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
- Hoehn and Yahr Stage III or IV
- Parkinson's disease observed in the absence of:
Show all 12Show fewer
- Oculomotor palsy
- Cerebellar sign
- Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
- Pyramidal sign
- Amyotrophy
- Good general health or stable medical condition well controlled, without contraindications to anesthesia
Who cannot join
- Patients with severe dementia and brain atrophy on MRI
- Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
- Patients older than 85 or younger than 35
- Patients who withhold informed consent
- Patients with a history of alcohol or drug abuse
- Sexually active women of childbearing potential without adequate form of birth control
Show all 11Show fewer
- Evidence of abnormal coagulation or anticoagulant therapy
- Pregnancy or lactation
- History of seizure disorders or current use of antiepileptic medication
- Severe cognitive impairment
- Clinically significant laboratory abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Neurosurgical Institute
Los Angeles, California, 90211
About this study
Official title: Molecular Analysis of Adult Human-derived Neural Stem Cells
The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease.
Read the detailed description
In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study.
- Conditions
- Parkinson's Disease, Parkinsonism
- Being tested
- Harvesting of neural stem cells
- Keywords
- Parkinson's disease, Neural stem cells
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting of neural stem cellsProcedure or surgery
During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.
| Study group | Role | What they receive |
|---|---|---|
| Neural stem cells | Not described Receives: Procedure: Harvesting of neural stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal differentiation into dopaminergic neurons
Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study start30 Jun 2011
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson'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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroGeneration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michel F. Levesque, MD, NeuroGeneration
- Investigators
- Michel F Levesque, MD, Principal investigator, Los Angeles Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329926
- Sponsor's protocol ID
- NGN-9001
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2011
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Adult Human-derived Neural Stem Cells
- ClinicalTrials.gov ID
- NCT01329926
- Acronym / sponsor ID
- NGN-9001
- Conditions
- Parkinson's Disease, Parkinsonism
- Keywords
- Parkinson's disease, Neural stem cells
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroGenerationIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Apr 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.
The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease.
Detailed description
In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural stem cells | – | Procedure: Harvesting of neural stem cells |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease or parkinsonism
Key inclusion criteria (12 listed)
- Able to give informed consent prior to study
- Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
- Age 35 to 85 years old
- Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
- Hoehn and Yahr Stage III or IV
Key exclusion criteria (11 listed)
- Patients with severe dementia and brain atrophy on MRI
- Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
- Patients older than 85 or younger than 35
- Patients who withhold informed consent
- Patients with a history of alcohol or drug abuse
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 |
|---|---|---|
| Harvesting of neural stem cellsDuring neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted. | Procedure or surgery | Neural stem cells |
Primary outcome
Neuronal differentiation into dopaminergic neurons
Time frame: 6 months
Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure
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 12 Apr 2022.
- Related InfoLink provided by the sponsor.
Related trials for Parkinson's Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
Parkinson Disease
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.
Michel F Levesque, MD principal investigator
Los Angeles Neurosurgical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonism, run by NeuroGeneration at 1 site in United States.
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 12 inclusion and 11 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 12 Apr 2022. 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 United States. 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.
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?
Neuronal differentiation into dopaminergic neurons (time frame: 6 months). 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 12 Apr 2022.