Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism
NCT06858254, Phase 1, Phase 2, Not yet recruiting, Apeiron Research Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism | ClinicalTrials.gov |
| NCT number | NCT06858254 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Apeiron Research Center | ClinicalTrials.gov |
| Conditions | Atypical Parkinsonism, Parkinson Disease (PD) | ClinicalTrials.gov |
| Interventions | Autologous mesenchymal stem cells | ClinicalTrials.gov |
| First posted | 2025-03-05 | ClinicalTrials.gov |
| Last updated | 2025-03-05 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III | Day 0, 6, 12 and 18 months | The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. Total scores can range from 0 to 141, with higher scores indicating worse disease severity. | ClinicalTrials.gov |
| Primary | 10-meter Walk Test (10MWT) | Day 0, 6, 12 and 18 months | The 10MWT is an assessment of gait speed over a short distance (2 meters ramp up, 6 meters walking, 2 meters ramp down). The aforementioned distances will be pre-measured for accuracy and only the middle 6 meters will be timed. Participants will be asked to walk at a comfortable pace for 2 trials and a fast pace for 2 trials. | ClinicalTrials.gov |
| Primary | Five Times Sit to Stand (FTSTS) | Day 0, 6, 12 and 18 months | The FTSTS objectively assesses the time it takes to complete 5 sit-to-stands and is a method to observe movement strategies or compensations. The test will be performed in a standard chair with participants instructed to stand up and sit down 5 times as quickly as possible. | ClinicalTrials.gov |
| Primary | Mini Balance Evaluation Systems Test (Mini-BESTest) | Day 0, 6, 12 and 18 months | The Mini-BESTest aims to target 6 different balance control systems. The measure includes 14 items assessing anticipatory postural adjustments, reactive balance control, sensory orientation, and dynamic gait. This is scored on a 3-item ordinal scale resulting in a maximum score of 28. | ClinicalTrials.gov |
| Primary | The Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in Parkinson's Disease - Motor Function (SPES/SCOPA - Motor) | Day 0, 6, 12 and 18 months | The SPES/Scales for Outcomes in Parkinson's will be used to evaluate motor function and includes 3 sections: Motor evaluation (10 items, maximum of 42 points), Activities of Daily Living (7 items, maximum 21 points), and Motor complications (4 items, maximum 12 points - with 2 items on motor fluctuation \[6 points\] and 2 on dyskinesias \[6 points\]). Response options for all items range 0 to 3. | ClinicalTrials.gov |
| Primary | Modified Hoehn & Yahr Scale | Day 0, 6, 12 and 18 months | The Modified Hoehn and Yahr Scale contains additional criteria to rate Parkinson disease symptoms on a scale of 1-5. Higher scores indicate increased disease progression. | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment (MoCA) | Day 0, 3, 6, 9, 12, 15 and 18 months | The MoCA is a rapid screen of cognitive abilities to detect mild cognitive dysfunction. Participants are tested on 16 items that cover multiple cognitive domains. The score ranges from 0-30, with higher scores indicating less cognitive impairment. | ClinicalTrials.gov |
| Primary | Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS) | Day 0, 6, 12 and 18 months | The PSP-CDS was developed to assess clinical deficits in patients with Progressive Supranuclear Palsy (PSP). The scale measures severity of deficits in seven patient-related clinical domains: Akinesia-rigidity, Bradyphrenia, Communication, Dysphagia, Eye movements, Finger dexterity, and Gait \& balance; each scored from 0 to 3. The sum of the individual domains provides a total score ranging from 0 (no deficit in any domain) to 21 (severe deficit in all domains) with higher scores representing a worse outcome. | ClinicalTrials.gov |
| Primary | Unified Multiple System Atrophy Rating Scale (UMSARS) | Day 0, 6, 12 and 18 months | The UMSARS will be used as a clinical rating scale to provide measures of disease progression in multiple systems atrophy. It is composed of four subscales: UMSARS-I (historical review of disease-related impairments, 12 items, scored 0 to 4), UMSARS-II (motor examination, 14 items, scored 0 to 4), UMSARS-III (autonomic examination - records blood pressure and heart rate in the supine and standing positions), and UMSARS-IV (global disability scale - rates chore-based disability, 1 item, ranges from 1 to 5). Higher scores on the UMSARS indicate greater disability. | ClinicalTrials.gov |
| Primary | Cortical Basal Ganglia Functional Scale (CBFS) | Day 0, 6, 12 and 18 months | The CBFS is a rating scale that evaluates experiences in daily living (EDLs), behavioral, language, and cognitive impairments in patients with 4 repeat tauopathies (4RTs). The CBFS consists of 14 questions on Motor EDLs and 17 questions on Non-motor EDLs, each of which are rated on a Likert scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems. The questions are for the patient, but should be answered by both the patient and their caregiver together. | ClinicalTrials.gov |
| Primary | Parkinson's Disease Questionnaire - 39 (PDQ-39) | Day 0, 3, 6, 9, 12, 15 and 18 months | The PDQ-39 is a self report questionnaire that assesses quality of life over the past month across 8 different dimensions (Activities of daily living, Attention and working memory, Cognition, Communication, Depression, Functional mobility, Quality of life, Social relationships, Social relationships, Social support). Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Each dimension total score ranges from 0 (never having difficulty) to 100 (always having difficulty) with lower scores being a better outcome. | ClinicalTrials.gov |
| Primary | The Scales for Outcomes in Parkinson's disease - Cognition (SCOPA-COG) | Day 0, 3, 6, 9, 12, 15 and 18 months | The SCOPA-COG consists of 10 items divided over four domains: memory (4 items), attention (2 items), executive function (3 items), and visuospatial function (1 item). Scores range from 0-43, with higher scores reflecting better performance. | ClinicalTrials.gov |
| Primary | The Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction | Day 0, 3, 6, 9, 12, 15 and 18 months | The SCOPA-AUT is self-completed by patients and consists of 23 items assessing the following domains: Gastrointestinal (7 items), Urinary (6 items), Cardiovascular (3 items), Thermoregulatory (4 items), Pupillomotor (1 item), and Sexual (2 items female, 2 items male). The maximum score is 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom). | ClinicalTrials.gov |
| Primary | Non-Motor Symptoms Questionnaire (NMSQ) | Day 0, 3, 6, 9, 12, 15 and 18 months | The NMSQ is a comprehensive assessment of a diverse range of non-motor symptoms which can occur in all stages of Parkinson's disease. It is a patient-based screening tool designed to draw attention to the presence of non-motor symptoms in patients. Responses are marked as "yes" or "no" in regard to symptoms over the past month. | ClinicalTrials.gov |
| Primary | MDS Non-Motor Rating Scale (MDS-NMS) | Day 0, 3, 6, 9, 12, 15 and 18 months | The MDS-NMS is a rater completed assessment that measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related. Scores are rated based on symptoms over the past month on frequency (scale from 0 to 4) and severity (scale 0 to 4), with higher scores reflecting more frequent and severe symptoms. | ClinicalTrials.gov |
| Secondary | Resting state brain activation pattern (fMRI analysis) | Day 0 and 18 months | An anatomical scan using fMRI at the University of Colorado Intermountain Neuroimaging Consortium will performed during a resting state to determine changes in atrophy pattern, volume, cortical thickness, ventricle enlargement, white matter hyperintensities, and magnetic inhomogeneity effects | ClinicalTrials.gov |
| Secondary | Active brain activation pattern (fMRI analysis) | Day 0 and 18 months | A motor sequencing tapping task and higher order cognitive task (Stroop test) at the University of Colorado Intermountain Neuroimaging Consortium will be performed during the fMRI to determine changes in atrophy pattern, volume, cortical thickness, ventricle enlargement, white matter hyperintensities, and magnetic inhomogeneity effects. | ClinicalTrials.gov |
| Secondary | Active performance accuracy and rate (fMRI analysis) | Day 0 and 18 months | A motor sequencing tapping task and higher order cognitive task (Stroop test) at the University of Colorado Intermountain Neuroimaging Consortium will be performed during the fMRI to determine changes accuracy and rate of responding for motor performance and cognitive performance. | ClinicalTrials.gov |
| Other | Intranasal Bone Marrow-Mesenchymal Stem Cells (BM-MSC) Indices | Day 0, 6 and 12 months | Number and viability of MSC's atomized | ClinicalTrials.gov |
| Other | Intravenous Bone Marrow-Mesenchymal Stem Cells (BM-MSC) Indices | Day 0, 6 and 12 months | Number and viability of MSC's infused | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)