SECRET-OA — UC-MSC Secretome for Knee Osteoarthritis Pain and Function, Phase 2/3
—
| Trial ID | NCT07337863 ↗ |
|---|---|
| Sponsor | Universitas Sriwijaya · Indonesia |
| Cell Source | 제대 중간엽줄기세포 (UC-MSC) · allogeneic |
| Indication | 무릎 골관절염 · Knee Osteoarthritis |
| Phase | PHASE 2 3 |
| Status | NOT-YET-RECRUITING |
| Delivery Route | intra-articular injection |
| Enrollment | 50 |
| Publication | — |
Trial Design
SECRET-OA is a randomised, double-blind, multi-centre Phase II/III clinical trial comparing UC-MSC-derived secretome with sodium hyaluronate in patients with knee osteoarthritis. Eligible participants are aged 40–70 years with Kellgren-Lawrence grade 2–3 disease. The experimental arm receives UC-MSC secretome via intra-articular injection; the control arm receives sodium hyaluronate. The primary endpoint is the change in WOMAC pain subscale score at 24 weeks.
Clinical Significance
This study is notable for using the secretome produced by mesenchymal stem cells rather than the cells themselves. The secretome may contain cytokines, growth factors, extracellular vesicles, and exosomes, and may offer manufacturing, storage, and quality-control advantages over cell-based products.
Reasons SECRET-OA is drawing attention:
- Cell-free therapeutic approach — MSC secretome used in place of the cells themselves
- Active comparator design — direct comparison against sodium hyaluronate
- Osteoarthritis indication — a chronic musculoskeletal condition with significant pain and functional limitation
- Phase 2/3 design — a comparative trial that goes beyond initial exploratory work
Limitations and Discussion
The primary endpoint focuses on pain as measured by the WOMAC pain subscale. However, osteoarthritis affects not only pain but also walking, rising from a seated position, balance, and stair-climbing — all of which reflect real-world functional capacity. Future research should incorporate objective physical performance measures alongside subjective scales such as WOMAC and VAS. The composition, potency assessment, and batch-to-batch consistency of the secretome also represent important regulatory and development challenges.