Trial reportJournal of orthopaedic surgery and research2025
Clinical efficacy of cell-free fat extract and its effects on bone marrow edema in patients with early to mid-stage knee osteoarthritis: a clinical trial in comparison with hyaluronic acid.
Trial report in Journal of orthopaedic surgery and research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Cell-Free Fat Extract (CEFFE) as a Versatile Cell-Free Biologic for Multitissue Regeneration: From Skin and Bone to Nerve, Reproductive, and Systemic Applications-A Comprehensive Review.BioMed research international · 2026Review
- Adipose Tissue-Derived Therapies for Osteoarthritis: Multifaceted Mechanisms and Clinical Prospects.Cells · 2025Review
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Authors and funding
3 authors.
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Abstract
backgroundPrevious studies have shown that hyaluronic acid can delay the progression of knee osteoarthritis. Existing research has extracted a bright red fluid called cell-free fat extract from human adipose tissue, which may play an important role in delaying the progression of osteoarthritis. By comparing with intra-articular injection of hyaluronic acid, this study aimed to evaluate the effects of intra-articular injection of CEFFE on both clinical efficacy and the reduction of bone marrow edema in patients with early to mid-stage knee osteoarthritis.
methodsA total of 48 patients with KOA (Kellgren-Lawrence grade II-III) symptoms were randomly divided into CEFFE group (24 cases) and HA group (24 cases). The patients in the CEFFE group received five injections of CEFFE (2 ml, 1 time/week), and the patients in the HA group received five injections of HA (2 ml, 1 ml/10 mg, 1 time/week). All the patients underwent clinical assessments using rating scales, including VAS, WOMAC and Lysholm Knee Score. These assessments were conducted at pre-treatment and at 3-week, 6-week, 3-month, and 6-month follow-up timepoints post-treatment. The clinical efficacy was evaluated at the 6-month follow-up after the treatment. The changes in subchondral bone marrow edema before and 6 months after treatment were assessed by grading BME on MRI of the affected knees.
resultsA total of 52 knees from 46 patients were included in the final analysis. Comparison of VAS score, WOMAC score, and Lysholm score between the two groups revealed that the differences between pre-treatment and 3 weeks post-treatment were not statistically significant (P > 0.05). For the VAS score and WOMAC score at 6 weeks, 3 months, and 6 months post-treatment, the CEFFE group was lower than the HA group (P < 0.05). For the Lysholm score, the CEFFE group was higher than the HA group (P < 0.05). Compared with pre-treatment, VAS scores and WOMAC scores were lower and Lysholm scores were higher at all post-treatment time points (P < 0.05). At 6 months post-treatment, the clinical efficacy of the CEFFE group was significantly better than that of the HA group (P < 0.05). At 6 months post-treatment, MRI grading showed that subchondral BME was reduced to different degrees in both groups, with the reduction being more pronounced in the CEFFE group (P < 0.05).
conclusionThis study demonstrated that intra-articular injection of CEFFE into the knee joint could enhance the durability of tissue-specific cells (especially chondrocytes) and improve cellular metabolic processes, preventing the continued progression of osteoarthritis. Both CEFFE and HA were found to improve clinical symptoms and reduced subchondral bone marrow edema in the treatment of early to mid-stage knee osteoarthritis. However, CEFFE was more effective than HA in achieving these outcomes.
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