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

August 24, 2021 updated by: Fatima Jamali, University of Jordan

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).

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Cell Therapy Center, University of Jordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • injection of Umbilical cord derived MSCs differentiated into neural stem cells NSCs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Tractography
Time Frame: 6 months
Gait and balance analysis system.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

July 30, 2020

Study Completion (ANTICIPATED)

September 20, 2021

Study Registration Dates

First Submitted

September 23, 2018

First Submitted That Met QC Criteria

September 23, 2018

First Posted (ACTUAL)

September 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUJCTC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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