Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorApeiron Research Center
About this trial
The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 40-75 years old with a diagnosis of PD or PPS (DLB, PSP, MSA, CBD with parkinsonism) based upon clinical criteria and standardized testing
Participants time of documented PD or PPS is </= 6 years
Participants with an anticipated survival of at least 3 years in the investigator's opinion
Participants who are willing and able to give informed consent
Disqualifiers
Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
Unable to receive/tolerate neuroimaging (e.g., MRI-incompatible cardiac pacemaker)
Unable to maintain/tolerate supine position with cervical neck extension
Trial design
Design model
Crossover
Treatments tested in this trial
Autologous mesenchymal stem cells
Biological/Vaccine1. Participant's blood is drawn at the start of each visit. 2. Bone marrow aspirate is drawn from the posterior aspect of the pelvis and is subsequently harvested and processed. 3. The following procedures are administered in a crossover design (Day 0 and 6 months): * Intranasal bone marrow aspirate administration (INA BMAC) OR Sham INA * Intravenous bone marrow aspirate administration (IV BMA) OR Sham IVA 4. At 12 months, all participants receive IV BMA + INA BMAC
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Parkinson Disease Group 1Experimental treatment 1 intervention
Group B: Parkinson Plus Syndrome Group 1Experimental treatment 1 intervention
Group C: Parkinson Disease Group 2Experimental treatment 1 intervention
Group D: Parkinson Plus Syndrome Group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III
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.
Time frame
Day 0, 6, 12 and 18 months2
10-meter Walk Test (10MWT)
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.
Time frame
Day 0, 6, 12 and 18 months3
Five Times Sit to Stand (FTSTS)
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.
Time frame
Day 0, 6, 12 and 18 months4
Mini Balance Evaluation Systems Test (Mini-BESTest)
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.
Time frame
Day 0, 6, 12 and 18 monthsSecondary outcomes
1
Resting state brain activation pattern (fMRI analysis)
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
Time frame
Day 0 and 18 months2
Active brain activation pattern (fMRI analysis)
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.
Time frame
Day 0 and 18 months3
Active performance accuracy and rate (fMRI analysis)
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.
Time frame
Day 0 and 18 monthsOther outcomes
1
Intranasal Bone Marrow-Mesenchymal Stem Cells (BM-MSC) Indices
Number and viability of MSC's atomized
Time frame
Day 0, 6 and 12 months2
Intravenous Bone Marrow-Mesenchymal Stem Cells (BM-MSC) Indices
Number and viability of MSC's infused
Time frame
Day 0, 6 and 12 months3
Bone Marrow (BM) Indices Comparative Analysis
Comparative analysis over the study period on the effects of multiple harvest interventions and differential cell counts on MSCs counts/viabilities
Time frame
Day 0, 6, 12 and 18 months4
Complete Blood Count (CBC) Indices Comparative Analysis
Comparative analysis over the study period on the effects of multiple harvest interventions and differential cell counts on CBC counts/viabilities
Time frame
Day 0, 6, 12 and 18 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Apeiron Research Center
Lead sponsor
University of Colorado, Boulder
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: