Parkinson's DiseasePhase 1/2NCT03309514
Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's Disease
A Phase 1/2 study testing Intracerebral microinjections in people with Parkinson's Disease, run by NeuroGeneration.
Trial summary
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with 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
- What is being tested?
- Intracerebral microinjections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to 30 Jun 2024
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent prior to study
- Male or Female with Diagnostic Criteria of Parkinson's disease
- 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:
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- 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
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- 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
About this study
Official title: Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.
- Conditions
- Parkinson's Disease
- Being tested
- Intracerebral microinjections
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracerebral microinjectionsBiological
Stereotactic delivery of cell suspension into basal ganglia structures
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Biological: Intracerebral microinjections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor UPDRS
UPDRS Motor scale
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 posted13 Oct 2017
- Study startJun 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309514
- Sponsor's protocol ID
- NGN-9076
- Status last verified
- Apr 2022
- First submitted
- 10 Oct 2017
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
- Clinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03309514
- Acronym / sponsor ID
- NGN-9076
- Conditions
- Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroGenerationIndustry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Oct 2017 (actual)
- 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.
This is a prospective study to demonstrate the safety and efficacy of differentiated neurons-derived from adult CNS progenitors cells transplanted in selected patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Intracerebral microinjections |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to give informed consent prior to study
- Male or Female with Diagnostic Criteria of Parkinson's disease
- 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 |
|---|---|---|
| Intracerebral microinjectionsStereotactic delivery of cell suspension into basal ganglia structures | Biological | Treatment |
Primary outcome
Motor UPDRS
Time frame: 6 months
UPDRS Motor scale
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intracerebral microinjections in people with Parkinson's Disease, run by NeuroGeneration.
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.
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?
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?
Motor UPDRS (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; AzTrials last refreshed its copy on 8 Nov 2026.