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Trial · NCT07896187

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Adverse EventsFrom the time of cell infusion up to 12 months after NCR201 transplantationTo evaluate the safety and tolerability of stereotactic intracerebral injection of NCR201 by assessing the type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs).
PrimaryMaximum Tolerated Dose (MTD) of NCR201Within 12 months after NCR201 transplantationChange from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
SecondaryChange in Unified Parkinson's Disease Rating Scale (UPDRS) Part III ScoreBaseline, 3 months, 6 months and 12 months after NCR201 transplantationChange from baseline in UPDRS Part III motor score to evaluate motor function improvement following NCR201 cell injection.
SecondarySurvival and engraftment of grafted cells assessed by brain PET/MRI imagingBaseline, 6 months and 12 months after NCR201 transplantationBrain PET and MRI imaging to evaluate the survival, location and engraftment of transplanted NCR201 dopaminergic progenitor cells in the putamen.
SecondaryChange in UPDRS Part II Activities of Daily Living ScoreBaseline, 3 months, 6 months and 12 months after NCR201 transplantationChange from baseline in UPDRS Part II score to assess activities of daily living in Parkinson's subjects after NCR201 treatment.
SecondaryChange in levodopa equivalent daily dose (LEDD)Baseline, 3 months, 6 months and 12 months after NCR201 transplantationChange from baseline in levodopa equivalent daily dose (LEDD) to assess reduction of anti-parkinson medication requirement.
SecondaryChange in UPDRS Part I Non-motor Experiences of Daily Living ScoreBaseline, 3 months, 6 months and 12 months after NCR201 transplantationChange from baseline in UPDRS Part I score to evaluate non-motor symptoms in Parkinson's patients receiving NCR201.
SecondaryIncidence of anti-NCR201 alloantibody formationBaseline, 1 month, 3 months, 6 months and 12 months after NCR201 transplantationDetection of anti-donor alloantibodies in peripheral blood to assess immune response against transplanted NCR201 cells.
SecondaryChange in Parkinson's Disease Questionnaire (PDQ-39) quality of life scoreBaseline, 6 months and 12 months after NCR201 transplantationChange from baseline in PDQ-39 total score to evaluate health-related quality of life after NCR201 cell transplantation.
SecondaryChange in dyskinesia rating scale scoreBaseline, 3 months, 6 months and 12 months after NCR201 transplantationChange from baseline in dyskinesia rating scale to assess the severity of levodopa-induced dyskinesia.
SecondaryDuration of on-time without troublesome dyskinesiaBaseline, 3 months, 6 months and 12 months after NCR201 transplantationAssessment of daily "on" time without troublesome dyskinesia based on patient diaries after NCR201 treatment.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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