Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03684122
• Date of registration: 23/09/2018
• Prospective Registration: No
• Primary sponsor: University of Jordan
• Public title: Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).
• Scientific 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).
• Date of first enrolment: June 1, 2018
• Target sample size: 10
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03684122
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Jordan

Contacts

• Name: Abdallah Awidi, MD
• Affiliation: Cell Therapy Center

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Biological: Injection of Umbilical cord derived MSCs

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection [Time Frame: 6 months]

Secondary Outcome(s)

Drug Reduction Rate test [Time Frame: 6 months]

Tractography [Time Frame: 6 months]

Blood-based biomarkers [Time Frame: 6 months]

Cerebrospinal Fluid (CSF) based biomarkers [Time Frame: 6 months]

Secondary ID(s)

PKUJCTC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors