Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glenohumeral Osteoarthritis
- Hip Osteoarthritis
- Knee Osteoarthritis
- Osteoarthritis
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 75 years
- Gender
- Both males and females
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. ...
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.
Tracking Information
- NCT #
- NCT03866330
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marek Postula, MD, PhD Medical University of Warsaw