Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis

Status Recruiting

Clinical Trial Summary

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive every three months a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) form the Polish Stem Cell Bank for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection.

Clinical Trial Description

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. All patients are selected and sign consent forms, then divided into 3 groups based on clinical presentation. Subjects will receive a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) prepared by the Polish Stem Cell Bank every three months for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection. During the study period and 24 months after last injection they will be followed by clinical assessment, laboratory investigations including inflammatory markers and microRNA, as well as magnetic resonance imaging (MRI) of the injected joint. The investigators will also determine the local and systemic safety of the procedure and therapy with WJMSC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03866330
Study type	Interventional
Source	Medical University of Warsaw
Contact	Marek Postula, MD, PhD
Phone	+48605113346
Email	mpostula@wum.edu.pl
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	March 1, 2019
Completion date	March 1, 2022

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