Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 16, 2021
Date Accepted: Jul 21, 2021
A New Tool for Safety Evaluation and a Combination of Measures for Efficacy Assessment of Co-Transplanting Human Allogenic Neuronal Stem Cells and Mesenchymal Stem Cells for the Treatment of Parkinson’s Disease: Interventional study protocol
ABSTRACT
Background:
Parkinson’s disease (PD) is a neurodegenerative disorder associated with a broad spectrum of motor and non-motor symptoms. Any proposed cure needs to improve the many aspects of the disease. Stem cell therapy has potential in those regards as indicated in recent preclinical and clinical studies.
Objective:
This protocol examines the safety and therapeutic benefit of human Wharton Jelly -derived Mesenchymal Stem Cells (WJ-MSCs) and their derivatives; Neuronal Stem Cells (NSCs) in PD.
Methods:
This clinical trial is a double-arm, single-blinded, phase I/ II interventional study. Participants are allocated into one of two groups; one receiving allogeneic WJ-MSCs only, the other receiving NSCs and WJ-MScs. Participants are followed-up and assessed over a period of six months. An Incidence of Treatment-Emergent Adverse Events (TEAEs) tool tailored for PD is used for immediate and up to 6 months post treatment safety assessment. The golden standard severity test UPDRS is used to study the efficacy of the treatment. In addition, standardized assessments for different common symptoms in PD have been included; 1) motor; both subjectively and objectively using wearable sensors, 2) sensory , 3)quality of life and psychological wellbeing, 4) cognitive and 5) sleep quality. Furthermore, immune-modulatory cytokines and neuronal damage versus regeneration markers in PD are monitored on the protein level including α-synuclein and DJ-1.
Results:
NA this is a protocol paper
Conclusions:
The combination of NSCs and MSCs in PD aims to harness the best of immunomodulation and neural repair characteristics of these cell types. The tailored comprehensive and scaled TEAEs measure and the variety of evaluation tools used enables a comprehensive assessment of this cellular therapy treatment protocol. It is important to consider such expanded tools in the design of future clinical studies for PD. Clinical Trial: This clinical study number: NCT 03684122, Registered 25 September 2018, https://clinicaltrials.gov/ct2/show/NCT03684122?cond=Parkinson+stem+cells+neural+stem+cells&cntry=JO&draw=2&rank=1
Citation
Per the author's request the PDF is not available.
Copyright
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