NCT03866330

Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis

Effectiveness of Wharton's Jelly-derived Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis
• Hip Osteoarthritis
• Knee Osteoarthritis
• Glenohumeral Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Intraarticular injection of WJMSC	ultrasound guided intra-articular injection of at least 10 million of Wharton's jelly-derived mesenchymal stem cells per procedure

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-12-01
• Completion: 2022-03-01
• First posted: 2019-03-07
• Last updated: 2019-03-08

Locations

1 site across 1 country: Poland