Use of Mesenchymal Stem Cells in Parkinson Disease (PD)
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|ClinicalTrials.gov Identifier: NCT03684122|
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Biological: Injection of Umbilical cord derived MSCs||Phase 1 Phase 2|
Parkinson's disease (PD) is one of the most common neurodegenerative disorders of aging, affecting about 1 % of the population aged 60 years and older and 3-5 % of the population above the age of 85 . It is characterized by the loss of dopamine neurons (DA neurons) in the substantial nigra, leading to the advent of both motor symptoms and non-motor symptoms .
This study is predicted to confirm the safety of the use of allogeneic MSCs 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. 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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of the Effects of Umbilical Cord Derived Mesenchymal Stem Cells (MSCs) Treatment for Parkinson's Disease Patients|
|Actual Study Start Date :||June 24, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Injection of Umbilical cord derived MSCs
Allogenic Umbilical Cord derived stem cells injected intrathecally 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
- 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
- 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.
- Tractography [ Time Frame: 6 months ]Gait and balance analysis system.
- 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.
- 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.
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
|Contact: Fatima Ab Jamali, PhD||009625355000 ext email@example.com|
|Contact: Dana Ma Hattab, PhD||009625355000 ext firstname.lastname@example.org|
|Cell Therapy Center, University of Jordan||Recruiting|
|Amman, Jordan, 11942|
|Contact: Fatima Jamali, PhD 009625355000 ext 23960 email@example.com|
|Study Director:||Abdallah Awidi, MD||Cell Therapy Center|