Trial · NCT05635409
A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease
NCT05635409, Phase 1, Active not recruiting, Region Skane
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease. Trials, record NCT05635409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05635409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease
- NCT number
- NCT05635409
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 8 participants, estimated
- Lead sponsor
- Region Skane
- Conditions
- Parkinson Disease
- Interventions
- STEM-PD
- First posted
- 2022-12-02
- Last updated
- 2025-12-17
- Other registries' IDs
- eudract:2021-001366-38
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The number and nature of adverse events and serious adverse events in the first 12 months following transplantation | 12 months following transplantation | Adverse events are recorded from the point of participant informed consent and at every trial visit |
| Primary | Absence of space occupying masses on cranial MRI in the first 12 months following transplantation | 12 months following transplantation | Magnetic resonance imaging (MRI) scans |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; emergence of new neurological features, | 36 months following transplantation | A physical examination, to include a review of all body systems as per standard practice will be performed to identify any clinical changes. Specifically, any signs of graft-induced dyskinesias (GIDs) will be looked for. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the Montreal Cognitive Assessment (MoCA) | 36 months following transplantation | The Montreal Cognitive Assessment (MoCA) is a 30-question test of global cognitive function, which evaluates different types of cognitive abilities, including: orientation, short-term memory, executive function, visuospatial ability, language ability, abstraction, animal naming, and attention. The maximum score is 30 and a score of \>26 is considered normal. A higher score is considered a better outcome. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the Hopkins verbal learning task-revised (HVLT-R) | 36 months following transplantation | The HVLT-R consists of a 12-item word list, composed of four words each from one of three semantic categories to be learned over the course of three immediate recall learning trials. Participants are also required to undergo a delayed recall trial (requiring free recall of any of the words remembered) and a recognition trial (composed of 24 words, including the 12 target words plus 12 false-positives. A point is given for each correct word and a higher score is considered a better outcome. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using semantic (animal naming) fluency | 36 months following transplantation | Participants are asked to name as many animals as possible in 90 seconds. One point is scored for admissible response. A higher score considered a better outcome. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the stroop test | 36 months following transplantation | The Stroop test is a measure of verbal processing speed and response inhibition, consisting of three timed trials. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the Digit Span test. | 36 months following transplantation | Participant is read a list of numbers and asked to repeat the numbers back to the assessor. The lists of numbers gradually gets longer until the participant is unable to remember all of the digits. A backwards span assessment is also completed where the participant is asked to repeat the numbers back in a reverse order. One point is scores for each verbatim correct repetition. The total Digit Span total score is a sum of all the forwards and backward scores. A higher score is a better outcome. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the Boston naming task. | 36 months following transplantation | In the Boston naming task participants are shown a number of images and are asked to say what the image is. This protocol uses a shortened 15-item version (Lansing et al., 1999) designed for use in patients with neurodegenerative disease. One point for every correct response. |
| Secondary | Changes in clinical effects at 36 months following transplantation compared to baseline; global cognitive changes assessed using the Wechsler Adult Intelligence Scale (WAIS) similarities test | 36 months following transplantation | The WAIS similarities assessment includes 14 pairs of words, where participants are asked to name how they are alike or similar. Tests are scored out of 28 and a higher score is considered a better outcome. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers47
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05635409
GET https://conductscience.org/api/trials/v1/NCT05635409/registered?page=2