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

NCT03684122 | Unknown Phase 1 DMC

• 1 other identifier: PKUJCTC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the short term and long term safety outcomes of the treatment of PD patients with umbilical cord derived stem cells as indicated by the presence of adverse events that are confirmed to be related to the therapy.

Conditions

Parkinson Disease

Keywords

Umbilical cord Mesenchymal Stem Cells; Parkinson Disease; Neurodegenerative; allogeneic

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection

  Side effects will be reported as Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, related TEAEs, severe TEAEs

  6 months

Secondary Outcomes (4)

• Drug Reduction Rate test

  6 months

• Tractography

  6 months

• Blood-based biomarkers

  6 months

• Cerebrospinal Fluid (CSF) based biomarkers

  6 months

Study Arms (2)

Injection of Umbilical cord derived MSCs

EXPERIMENTAL

Allogenic Umbilical Cord derived stem cells injected intravenously to enrolled PD patients

Biological: Injection of Umbilical cord derived MSCs

Injection of MSCs differentiated into neural stem cells NSCs

EXPERIMENTAL

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

Interventions

Injection of Umbilical cord derived MSCs BIOLOGICAL

Allogenic umbilical cord derived MSCs which are to be injected intrathecally and intravenously as a treatment option for consenting PD patients

Also known as: injection of Umbilical cord derived MSCs differentiated into neural stem cells NSCs.

Injection of MSCs differentiated into neural stem cells NSCs; Injection of Umbilical cord derived MSCs

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Cell Therapy Center, University of Jordan

Amman, 11942, Jordan

Location

Related Publications (1)

• Jamali F, Aldughmi M, Khasawneh MW, Dahbour S, Salameh AA, Awidi A. A New Tool for Safety Evaluation and a Combination of Measures for Efficacy Assessment of Cotransplanting Human Allogenic Neuronal Stem Cells and Mesenchymal Stem Cells for the Treatment of Parkinson Disease: Protocol for an Interventional Study. JMIR Res Protoc. 2021 Oct 22;10(10):e29695. doi: 10.2196/29695.

  PMID: 34677138 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Abdallah Awidi, MD

  Cell Therapy Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neuroscience Research

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 25, 2018
• Study Start: June 1, 2018
• Primary Completion: July 30, 2020
• Study Completion: September 20, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

JO (1)