Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
NCT03866330 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2019-03-08
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.
Conditions
- Osteoarthritis
- Hip Osteoarthritis
- Knee Osteoarthritis
- Glenohumeral Osteoarthritis
Interventions
- 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
Sponsors & Collaborators
-
Medical University of Warsaw
lead OTHER
Principal Investigators
-
Marek Postula, MD, PhD · Medical University of Warsaw
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-01
- Primary Completion
- 2019-12-31
- Completion
- 2022-03-01
Countries
- Poland
Study Locations
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