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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Allogenic umbilical cord derived MSCs which are to be injected intrathecally and intravenously as a treatment option for consenting PD patients
Cell Therapy Center, University of Jordan
Amman, Jordan
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
Time frame: 6 months
Drug Reduction Rate test
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.
Time frame: 6 months
Tractography
Gait and balance analysis system.
Time frame: 6 months
Blood-based biomarkers
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.
Time frame: 6 months
Cerebrospinal Fluid (CSF) based biomarkers
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.
Time frame: 6 months
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