Ismail Hadisoebroto Dilogo1,2,3, Anissa Feby Canintika4, Alberto Lastiko Hanitya4, Jeanne Adiwinata Pawitan5,6,7, Isabella Kurnia Liem5,6,8, Jacub Pandelaki9. 1. Department of Orthopaedics and Traumatology, Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. ismailortho@gmail.com. 2. Stem Cell Medical Technology Integrated Medical Service Unit, Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. ismailortho@gmail.com. 3. Stem Cell and Tissue Engineering Research Center, IMERI, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. ismailortho@gmail.com. 4. Department of Orthopaedics and Traumatology, Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. 5. Stem Cell Medical Technology Integrated Medical Service Unit, Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. 6. Stem Cell and Tissue Engineering Research Center, IMERI, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. 7. Department of Histology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. 8. Department of Anatomy, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. 9. Department of Radiology, Cipto Mangunkusumo General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Abstract
BACKGROUND: Despite being a common cause of quality-of-life impairment, there are no efficacious therapies that could prevent the progression of knee osteoarthritis (KOA). We conducted an open-label trial of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) and hyaluronic acid (HA) for treating KOA. METHODS: This open-label study was conducted from July 2015 to December 2018 at Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Patients diagnosed with KOA were injected three times, comprising of 10 × 106 units of hUC-MSCs in 2-ml secretome implantation and 2-ml hyaluronic acid (HA) injection in the first week, followed with 2-ml HA injection twice in the second and third week. RESULTS: Twenty-nine subjects (57 knees) were recruited. Seventeen (58.6%) subjects were male, and the mean age was 58.3 ± 9.6 years. Thirty-three (57.9%) knees were classified into Kellgren-Lawrence grade I-II KOA (mild OA). hUC-MSCs significantly decreased pain measured by visual analogue scale in severe KOA from initial to 6th month follow-up [5 ± 2.97 to 3.38 ± 2.44 (p = 0.035)]. The International Knee Documentation Committee score significantly increased at 6th month follow-up (53.26 ± 16.66 to 65.49 ± 13.01, p < 0.001, in subjects with grade I-II and 48.84 ± 18.41 to 61.83 ± 18.83, p = 0.008, in subjects with severe KOA). The Western Ontario and McMaster Universities Osteoarthritis decreased significantly in both groups from initial to 6th month follow-up (from 22.55 ± 15.94 to 13.23 ± 10.29, p = 0.003, and from 27.57 ± 15.99 to 17.92 ± 19.1, p = 0.003, in those with mild and severe KOA, respectively). CONCLUSIONS: hUC-MSCs could be a potentially new regenerative treatment for KOA. The maximum effect of hUC-MSCs was achieved after 6 months of injection. LEVEL OF EVIDENCE: Therapeutic level II.
BACKGROUND: Despite being a common cause of quality-of-life impairment, there are no efficacious therapies that could prevent the progression of knee osteoarthritis (KOA). We conducted an open-label trial of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) and hyaluronic acid (HA) for treating KOA. METHODS: This open-label study was conducted from July 2015 to December 2018 at Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Patients diagnosed with KOA were injected three times, comprising of 10 × 106 units of hUC-MSCs in 2-ml secretome implantation and 2-ml hyaluronic acid (HA) injection in the first week, followed with 2-ml HA injection twice in the second and third week. RESULTS: Twenty-nine subjects (57 knees) were recruited. Seventeen (58.6%) subjects were male, and the mean age was 58.3 ± 9.6 years. Thirty-three (57.9%) knees were classified into Kellgren-Lawrence grade I-II KOA (mild OA). hUC-MSCs significantly decreased pain measured by visual analogue scale in severe KOA from initial to 6th month follow-up [5 ± 2.97 to 3.38 ± 2.44 (p = 0.035)]. The International Knee Documentation Committee score significantly increased at 6th month follow-up (53.26 ± 16.66 to 65.49 ± 13.01, p < 0.001, in subjects with grade I-II and 48.84 ± 18.41 to 61.83 ± 18.83, p = 0.008, in subjects with severe KOA). The Western Ontario and McMaster Universities Osteoarthritis decreased significantly in both groups from initial to 6th month follow-up (from 22.55 ± 15.94 to 13.23 ± 10.29, p = 0.003, and from 27.57 ± 15.99 to 17.92 ± 19.1, p = 0.003, in those with mild and severe KOA, respectively). CONCLUSIONS: hUC-MSCs could be a potentially new regenerative treatment for KOA. The maximum effect of hUC-MSCs was achieved after 6 months of injection. LEVEL OF EVIDENCE: Therapeutic level II.
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