"A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease"

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (52 points total)

Reporting status

POSTED

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · % of white blood cell count

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of % of white blood cell count.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · 10^9 cells/L

Reporting status

POSTED

Changes from baseline in CBC laboratory values with units of 10\^9 cells/L (Leukocytes, Platelets)

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · 10^12 cells/L

Reporting status

POSTED

Changes from baseline in CBC laboratory values with units of 10\^12 cells/L.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · pg

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of pg.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · fL

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of fL.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · g/dL

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of g/dL.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · % difference in volume and size of RBC

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · % of total blood cell count

Reporting status

POSTED

Changes from baseline in CBC laboratory values with unit of % of total blood cell count.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · mmHg

Reporting status

POSTED

Change from baseline in Blood Pressure.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · kg

Reporting status

POSTED

Change from baseline in Weight in kg.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · mg/dL

Reporting status

POSTED

Change from baseline in CMP values with units of mg/dL

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · g/dL

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of g/dL

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · IU/L

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of IU/L.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · mL/min/1.73m^2

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · mmol/L

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of mmol/L.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · Ratio: Albumin(g/dL) to Globulin(g/dL)

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · Ratio:Urea nit.(mg/dL) /creatinin(mg/dL)

Reporting status

POSTED

Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · seconds

Reporting status

POSTED

Changes from baseline in Coagulation Panel values with units of seconds.

Time frame

Baseline (Week 0), Week 24, and End of Study (Week 52)

Measure

MEAN · Ratio: PT (seconds) / MNPT (seconds)

Reporting status

POSTED

Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · breaths/minute

Reporting status

POSTED

Changes from Baseline in Respiratory Rate.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · beats/minute

Reporting status

POSTED

Change from baseline in Heart Rate.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · Celsius

Reporting status

POSTED

Change from baseline in Body Temperature.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (52 points total)

Reporting status

POSTED

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (132 points total)

Reporting status

POSTED

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part III tests "Motor examination". Motor Examination includes speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage. There are 18 items included in Part III. Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (24 points total)

Reporting status

POSTED

The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (25 points total)

Reporting status

POSTED

Communication - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The communication short form has 5 questions regarding communicative abilities of the patient, and each question ranges from 0 points to 5 points (making the total 25 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Ability to Participate in Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Ability to Participate in Social Roles and Activities" short form has 8 questions regarding social abilities of the patient (familial and friend relationships), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Anxiety - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Anxiety" short form has 8 questions regarding the anxiety level of the patient (inquiring about level of uneasiness and worry), and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Depression - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Depression" short form has 8 questions regarding the depression level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Emotional and Behavioral Dyscontrol - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Dyscontrol" short form has 8 questions regarding the emotional and behavioral dyscontrol level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Fatigue - Short Form Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Fatigue" short form has 8 questions regarding the Fatigue level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Lower Extremity Function (Mobility) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Mobility" short form has 8 questions regarding the Lower Extremity Function (Mobility) level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (45 points total)

Reporting status

POSTED

Positive Affect and Well-Being - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Positive Affect and Well-Being" short form has 8 questions regarding the well-being level of the patient, and each question ranges from 0 points to 5 points (making the total 45 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Sleep Disturbance - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Sleep disturbance" short form has 8 questions regarding the sleep level of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Upper Extremity Function (Fine Motor, ADL) - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Upper Extremity Function (Fine Motor, ADL)" short form has 8 questions regarding the fine motor levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Stigma-Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Stigma" short form has 8 questions regarding the stigma levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Satisfaction with Social Roles and Activities - Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Satisfaction with Social Roles and Activities" short form has 8 questions regarding the satisfaction levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (40 points total)

Reporting status

POSTED

Cognition Function- Short Form Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The "Cognition Function" short form has 8 questions regarding the cognition function levels of the patient, and each question ranges from 0 points to 5 points (making the total 40 points). A higher score represents a better outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (80 points total)

Reporting status

POSTED

The Parkinson's disease fatigue scale (PFS-16) is an 16 question assessment that measures the level of fatigue in patients diagnosed with Parkinson's disease. Each question has 5 answer choices established as "strongly disagree", "disagree", "do not agree or disagree", "agree", and "strongly agree", which are scored as 1 to 5, respectively, making the total score from 16 to 80 points. Higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (100 points total)

Reporting status

POSTED

The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100. The final reported score (summary index) is calculated by averaging the 8 scaled scores. Higher score represents a worse outcome.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · score on a scale (200 points total)

Reporting status

POSTED

Visual Analog Scale for Pain and Muscle Spasm. The pain and muscle spasm VAS is a unidimensional measure of pain/ muscle spasm intensity, used to record patients' pain progression and muscle spasm progression, or compare pain and muscle spasm severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark summed with the distance (mm) on the 10-cm line between the "no muscle spasm" anchor and the patient's mark, providing a range of scores from 0-200. A higher score indicates greater pain/spasm intensity.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · mg

Reporting status

POSTED

Dosage of medications.

Time frame

Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Measure

MEAN · percent of oxygen

Reporting status

POSTED

Changes in Oxygen Saturation.