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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04657926` - A Trial of APPA in the Treatment of Knee Osteoarthritis	Phase 2
Completed	`NCT02536833` - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects	Phase 2
Completed	`NCT03014037` - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration	N/A
Recruiting	`NCT05937542` - A Qualitative Investigation of CLEAT Participants
Completed	`NCT03644615` - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis	N/A
Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Withdrawn	`NCT04976972` - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT03850665` - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach	N/A
Completed	`NCT02826902` - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial	N/A
Completed	`NCT04402502` - Dynamic 4DCT to Examine Wrist Carpal Mechanics	N/A
Completed	`NCT02923700` - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial	Phase 4
Completed	`NCT04564053` - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants	Phase 1
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Not yet recruiting	`NCT05036174` - Diphenhydramine Ointment for Knee Osteoarthritis	N/A
Recruiting	`NCT02912429` - Onlay vs. Inlay Patellofemoral Arthroplasty	N/A
Recruiting	`NCT02666443` - Low Dose Dexamethasone in Supraclavicular Blocks	N/A
Active, not recruiting	`NCT02723929` - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Withdrawn	`NCT02921594` - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties	N/A
Terminated	`NCT02820766` - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting	N/A