Wharton's Jelly MSC for Knee Osteoarthritis — Polish Multi-Centre Phase I/II
Single ultrasound-guided intra-articular injection of 10 million WJ-MSCs targeting knee, hip, and shoulder OA.
| Trial ID | NCT03866330 ↗ |
|---|---|
| Sponsor | Medical University of Warsaw · Poland |
| Cell Source | 와튼젤리 중간엽줄기세포 (WJ-MSC) · allogeneic |
| Indication | 무릎 골관절염 · Knee Osteoarthritis |
| Phase | PHASE 1 2 |
| Status | ACTIVE |
| Delivery Route | intra-articular injection |
| Enrollment | 30 |
| Publication | — |
Trial Design
A non-randomised parallel-group trial led by the Medical University of Warsaw. Patients with osteoarthritis of the knee, hip, or shoulder joint receive a single ultrasound-guided intra-articular injection of at least 10 million Wharton’s jelly-derived MSCs per administration.
Design Notes
Unlike most OA trials that focus on a single joint — typically the knee — this study addresses three joint types (knee, hip, and shoulder) within a single protocol. Because each joint differs in load-bearing pattern and cartilage thickness, the dataset will provide a comparative view of how the same cell source and dose perform across anatomically distinct target sites.
The trial also explicitly designates integrated recovery-process analysis — encompassing inflammatory markers, microRNA profiling, and clinical outcome measures — as a secondary endpoint, representing a deliberate effort to track the mechanism of action of WJ-MSCs in a clinical setting.
Clinical Significance
The key advantages of WJ-MSCs in OA treatment are:
- Low immunogenicity due to fetal origin — low risk of rejection even in allogeneic use
- Superior proliferative capacity and differentiation potential compared to adult MSCs — favourable for large-scale manufacturing
- Minimal ethical burden — utilises umbilical cord tissue that would otherwise be discarded after delivery
A 2025 systematic review (JFB, Cassano et al.) analysing six WJ-MSC intra-articular injection trials (97 patients; 134 joints) found no serious adverse events and reported significant improvements in functional outcome measures including VAS, WOMAC, KOOS, and IKDC scores. Radiological outcomes (cartilage regeneration), however, were mixed, warranting further investigation.
Korean Adoption Perspective
In South Korea, autologous adipose-tissue MSC therapy for knee OA (e.g., Cartistem) is already commercially available; however, allogeneic WJ-MSCs remain in the clinical-stage. The primary advantage of allogeneic cells is off-the-shelf availability: the patient-specific harvesting and expansion steps are eliminated, reducing both cost and turnaround time. This cost structure may also facilitate more favourable health insurance reimbursement negotiations upon approval.