Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).
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ClinicalTrials.gov Identifier: NCT03684122 |
Recruitment Status :
Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : August 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Biological: Injection of Umbilical cord derived MSCs | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD). |
Actual Study Start Date : | June 1, 2018 |
Actual Primary Completion Date : | July 30, 2020 |
Estimated Study Completion Date : | September 20, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Injection of Umbilical cord derived MSCs
Allogenic Umbilical Cord derived stem cells injected intravenously to enrolled PD patients
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Biological: Injection of Umbilical cord derived MSCs
Allogenic umbilical cord derived MSCs which are to be injected intrathecally and intravenously as a treatment option for consenting PD patients
Other Name: injection of Umbilical cord derived MSCs differentiated into neural stem cells NSCs. |
Experimental: Injection of MSCs differentiated into neural stem cells NSCs
Allogenic Umbilical Cord derived stem cells (MSCs) differentiated into neural stem cells (NSCs) injected intrathecaly and intravenously to enrolled PD patients.
|
Biological: Injection of Umbilical cord derived MSCs
Allogenic umbilical cord derived MSCs which are to be injected intrathecally and intravenously as a treatment option for consenting PD patients
Other Name: injection of Umbilical cord derived MSCs differentiated into neural stem cells NSCs. |
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection [ Time Frame: 6 months ]Side effects will be reported as Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs
- Drug Reduction Rate test [ Time Frame: 6 months ]Based on reduction rate, the efficacy can be defined as complete remission, partial remission, effective and invalid. The reduction rate will be 100%, >50%, >25%-50%, ≤25% for complete remission, partial remission, effective and invalid.
- Tractography [ Time Frame: 6 months ]Gait and balance analysis system.
- Blood-based biomarkers [ Time Frame: 6 months ]Blood-based biomarkers will be analysed which include the concentration in ng/ul of α-synuclein, uric acid, epidermal growth factor, apolipoprotein-A1, and peripheral inflammatory markers using the 20-plex Luminex technology.
- Cerebrospinal Fluid (CSF) based biomarkers [ Time Frame: 6 months ]Cerebrospinal Fluid (CSF) based biomarkers such as α-synuclein (αSyn), β-amyloid 1-42 (Aβ42), tau,phosphorylated tau, and neurofilament light chain will be analyzed and their concentration were measured in ng/ul.

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non- smokers
- Diagnosis of PD between 1 to 7 years
- Robust response to dopaminergic therapy (defined as greater than 33% reduction in symptoms (on the Unified Parkinson's Disease Rating Scale; UPDRS) when measured in the ON medicine state compared to OFF state.
- If subject is taking any central nervous system acting medications (e.g., benzodiazepines, antidepressants, hypnotics) regimen must be optimized and stable for 90 days prior to the screening visit.
- A stable Parkinson's disease symptomatic therapy for at least 90 days prior to screening and not projected to require additional Parkinson's disease symptomatic therapy for at least one year from the baseline visit.
- Women of childbearing potential will be required to use a reliable form of contraception from 30 days prior to baseline visit until 6 months after treatment
- A clear infectious panel examination including Hepatitis B, C, Human immunodeficiency virus (HIV), Syphilis
Exclusion Criteria:
- Atypical or drug-induced Parkinsonism.
- A UPDRS rest tremor score of 3 or greater for any limb on medication
- A Montreal Cognitive Assessment (MoCA) score of less than 25.
- Clinical features of psychosis or refractory hallucinations.
- Uncontrolled seizure disorder, defined as a seizure within the last 6 months.
- Developmental delay.
- Hepatic disease or altered liver function as defined by alanine transaminase (ALT) >150 U/L and or T. Bilirubin >1.6 mg/dl at admission.
- Presence of clinically refractory orthostatic hypotension at the screening or baseline visit defined as greater than or equal to 20 mmHg change in systolic Blood pressure (BP) and greater than or equal to 10 mmHg change in diastolic BP from sitting position to standing after 2 minutes that does not respond to medical treatment or baseline sitting BP less than 90/60.
- History of congestive heart failure, clinically significant bradycardia, presence of 2nd or 3rd degree atrioventricular block.
- Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening (Cancer free for at least 5 years is permitted; skin cancers, except for melanoma, are permitted).
- History of strokes or traumatic brain injury.
- Major surgery within the previous 3 months or planned in the ensuing 6 months.
- Clinically significant abnormalities in the Screening Visit laboratory studies.
- History of use of an investigational drug within 30 days prior to the screening visit.
- History of brain surgery for PD.
- Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
- Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled or complicate the study assessments.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684122
Jordan | |
Cell Therapy Center, University of Jordan | |
Amman, Jordan, 11942 |
Study Director: | Abdallah Awidi, MD | Cell Therapy Center |
Responsible Party: | Fatima Jamali, Head of Neuroscience Research, University of Jordan |
ClinicalTrials.gov Identifier: | NCT03684122 |
Other Study ID Numbers: |
PKUJCTC |
First Posted: | September 25, 2018 Key Record Dates |
Last Update Posted: | August 25, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Umbilical cord Mesenchymal Stem Cells Parkinson Disease Neurodegenerative allogeneic |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |