Gold-Induced Cytokine (GOLDIC®) Therapy in the Management of Knee Osteoarthritis: An Observational Study

Abstract

Background: Current treatment modalities for knee osteoarthritis (OA) provide symptomatic cures rather than reversing the pathology in the long term. An innovative regenerative therapy called "Gold Induced Cytokines" (GOLDIC®) was explored in various musculoskeletal diseases such as knee OA, lumbar canal stenosis, Achilles tendinopathy, and plantar fasciitis. In this study, we explored the safety and functional outcome of GOLDIC® injections in knee OA (KL grades 3 and 4) with visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.

Materials and methods: A multi-center open-label observational study was carried out after screening the cases according to the inclusion criteria. A total of 106 knees in 65 patients were enrolled for four doses of 4 ml of ultrasound-guided intra-articular GOLDIC® injections every three to six days. All cases were followed up with pre- and post-VAS and WOMAC scores at an interval of four weeks, three months, six months, and one year, and the complications (including severe adverse reactions) were monitored throughout.

Results: In this study, 66.1% had grade 4 OA knee (without gross varus or subluxation) and 33.8% had grade 3 OA knee. All the participants underwent the GOLDIC® treatment modality. A statistically significant difference was observed in pre- and post-procedural follow-up in VAS and WOMAC scores at one-year follow-up. There were no recorded severe adverse reactions during the entire study period. Three patients failed the treatment in one year.

Conclusion: The GOLDIC® procedure shows great promise as a novel method for treating moderate to severe OA of the knee, both in terms of pain and functional outcome without any severe adverse reactions, in a sustained manner and is worth exploring as a long-term treatment option.

Keywords: cytokines; gelsolin; gold; knee; osteoarthritis.

Figure 1. Withdrawal of peripheral venous blood from the cubital vein in GOLDIC® BTS syringes (Arthrogen GmbH, Ringsee, Germany)

Picture courtesy of Dr. Sharmila Tulpule

Figure 2. Incubator for GOLDIC® BTS syringes (Arthrogen. GmbH, Ringsee, Germany) at 37°C for 24 hours

Picture courtesy of Dr. Sharmila Tulpule

Figure 3. Resultant serum after centrifugation at 4000 rpm for 10 minutes

Picture courtesy of Dr. Sharmila Tulpule

Figure 4. Filtration of supernatant-conditioned serum through a 0.22-μM syringe tip filter

Picture courtesy of Dr. Sharmila Tulpule

Figure 5. Final GOLDIC® injectate

Picture courtesy of Dr. Sharmila Tulpule

Figure 6. Global rating of change among the study participants