ClinicalTrials.gg
WithdrawnNCT01329926Updated Apr 12, 2022

Molecular Analysis of Human Neural Stem Cells

An observational study in Parkinson's Disease and Parkinsonism, sponsored by NeuroGeneration. Withdrawn at 1 site in United States. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by NeuroGeneration · Observational

Why this study was withdrawn
insufficient funding

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
35 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Enrollment
373rd of 379
0 · median 78
Started
2011
with 47 others
Observational
381 of 1,649
75 open now
Registered
363rd of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 373rd largest by enrollment of the 379 observational ones that give a count, is one of 48 that started in 2011, is one of 381 observational ones, and was the 363rd registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:

299 more — sign in →

All 304 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 35 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Parkinson's Disease
  • Parkinsonism

Keywords

  • Parkinson's disease
  • Neural stem cells
04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Parkinson's disease or parkinsonism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to give prior to study
  2. Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
  3. Age 35 to 85 years old
  4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
  5. Hoehn and Yahr Stage III or IV
  6. Parkinson's disease observed in the absence of:

    • Oculomotor palsy
    • Cerebellar sign
    • Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
    • Pyramidal sign
    • Amyotrophy
  7. Good general health or stable medical condition well controlled, without to anesthesia

Exclusion criteria

Exclusion Criteria:

  1. Patients with severe dementia and brain atrophy on MRI
  2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis,
  3. Patients older than 85 or younger than 35
  4. Patients who withhold
  5. Patients with a history of alcohol or drug abuse
  6. Sexually active women of without adequate form of
  7. Evidence of abnormal coagulation or anticoagulant therapy
  8. Pregnancy or lactation
  9. History of seizure disorders or current use of antiepileptic medication
  10. Severe cognitive impairment
  11. laboratory abnormality
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Neural stem cells

    Procedure: Harvesting of neural stem cells

Interventions

  • ProcedureHarvesting of neural stem cells

    During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.

06

What researchers measure

Primary outcomes

  1. Neuronal differentiation into dopaminergic neurons

    Differentiation of at least 10% of dopaminergic neurons is targeted as the primary outcome measure

    Time frame: 6 months

07

Study locations

1 site
  • Los Angeles Neurosurgical Institute
    Los Angeles, California 90211, United States
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Dec 2022 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2011
First posted
Apr 6, 2011
Start
Jun 30, 2011
Primary completionEst.
Dec 31, 2022
CompletionEst.
Dec 31, 2023
Last update
Apr 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01329926
Lead sponsor
NeuroGeneration
Responsible party
Michel F. Levesque, MD (Principal Investigator, NeuroGeneration) — Principal investigator
First posted
Apr 6, 2011
Start date
Jun 30, 2011
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 12, 2022

Study contacts

Michel F Levesque, MD
principal investigator · Los Angeles Neurosurgical Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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