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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684122
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Fatima Jamali, University of Jordan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Biological: Injection of Umbilical cord derived MSCs Phase 1 Phase 2

Detailed Description:
This study is predicted to confirm the safety of the use of allogeneic mesenchymal stem cell (MSCs) differentiated into neural stem cells (NSCs) in one of the most common neurological diseases. It will also aid in the better understanding of the role of stem cell therapy in relation to motor and non-motor symptoms in people with Parkinson disease. The safety outcomes would encourage launching similar larger studies. And also to facilitate the treatment and outcome results by giving differentiated mesenchymal stem cells (MSCs) into neural stem cells (NSCs) rather than allow the cells to differentiate inside the body. While the efficacy results if encouraging, would mean an improvement in the disability associated with PD and reduction in the life-time care and treatment provided to this category of patients in Jordan and the Arab region.
Study Design
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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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Injection of Umbilical cord derived MSCs
Allogenic Umbilical Cord derived stem cells injected 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Tractography [ Time Frame: 6 months ]
    Gait and balance analysis system.

  3. 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.

  4. 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.


Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Fatima Ab Jamali, PhD 009625355000 ext 23960 ftmjamali@gmail.com
Contact: Dana Ma Hattab, PhD 009625355000 ext 23960 d.hattab@ju.edu.jo

Locations
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Jordan
Cell Therapy Center, University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Fatima Jamali, PhD    009625355000 ext 23960    ftmjamali@gmail.com   
Sponsors and Collaborators
University of Jordan
Investigators
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Study Director: Abdallah Awidi, MD Cell Therapy Center
More Information
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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: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatima Jamali, University of Jordan:
Umbilical cord Mesenchymal Stem Cells
Parkinson Disease
Neurodegenerative
allogeneic
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases