Sains Malaysiana 52(10)(2023): 2773-2784

http://doi.org/10.17576/jsm-2023-5210-04

Chondrogen™ Injection for Knee Osteoarthritis using Stem Cells from Wharton's Jelly

(Suntikan Kondrogen™ untuk Osteoartritis Lutut menggunakan Sel Stem daripada Jeli Wharton)

BADRUL AKMAL HISHAM BIN MD YUSOFF¹, AHMAD FARIHAN BIN MOHD DON, NORLELAWATI BINTI MOHAMAD¹, RAMESH SARAVANAMUTHU², KARTHIK CHANDRAN², RAZIANA RASIB², PREMASANGERY KATHIVALOO² & FELIX LAU HUEY YIH¹

¹Department of Orthopaedics & Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Clinical Block, Jalan Yaacob Latiff, 56000 Cheras, Kuala Lumpur, Malaysia ²Meluha Therapeutics Sdn Bhd, Lot 1-2G, Lanai Complex, No.2 Persiaran Seri Perdana, 62250 Precinct 10, Putrajaya, Malaysia

Diserahkan: 15 Mei 2023/Diterima: 15 September 2023

Abstract

Knee osteoarthritis constitutes a prominent source of pain and functional impairment, with its prevalence showing a consistent yearly increase. Current therapeutic strategies primarily revolve around addressing symptoms and, in severe cases, resorting to prosthetic joint replacement, yet they fail to target the underlying pathophysiological mechanisms driving degeneration. In this context, there is a growing interest in investigating mesenchymal stem cell (MSC) therapy as a potential remedy for osteoarthritis. Among the various MSC types under scrutiny, using Wharton's Jelly-derived mesenchymal stem cells (WJ-MSCs) has garnered relatively scant attention. The present study represents a Phase I clinical trial of an open-label, single-arm design within this context. Its principal aim is to assess the safety and efficacy of administering mesenchymal stem cells derived from Wharton's Jelly via intra-articular injection for patients diagnosed with knee osteoarthritis. Throughout six months, this investigation discerned a statistically significant overall improvement in clinical presentation relative to baseline. This improvement manifested as reduced analgesic consumption, diminished Visual Analog Scale (VAS) scores (19.5 to 18.7 mm, p = .00), and augmented functional assessment scores, including the IKDC Score (enhanced from 62.2 to 100, p = .00), KOOS Symptoms and Stiffness subscales (elevated from 76.8% to 10.6%, p = .00), as well as KOOS Pain subscale (upgraded from 74.4% to 10.1%, p = .00). The study encouragingly reported no significant adverse effects during the observation period. However, upon radiographic evaluation, no significant alterations were observed in terms of deformity angle (p = 0.957) or medial (p = 0.871) and lateral (p = 0.520) compartment joint space widths. To further elucidate the comparative efficacy of this treatment, it is prudent to contemplate a randomised controlled trial comparing it against the conventional hyaluronic acid regimen, thereby contributing to an enriched understanding of its therapeutic potential.

Keywords: Knee; mesenchymal stem cell; osteoarthritis; percutaneous injection; Wharton's Jelly

Abstrak

Osteoartritis lutut merupakan sumber kesakitan dan kemerosotan fungsi yang ketara dengan kelazimannya menunjukkan peningkatan tahunan secara tekal. Strategi terapeutik pada masa ini kebiasaannya berkisar untuk menangani gejala dan dalam kes yang teruk, menggunakan pengganti sendi prostetik, namun ia gagal menyasarkan mekanisme patofisiologi yang menyebabkan kemerosotan. Dalam konteks ini, terdapat minat yang semakin meningkat untuk mengkaji terapi sel stem mesenkima (MSC) sebagai penyembuh berpotensi untuk osteoartritis. Antara pelbagai jenis MSC yang dikaji, penggunaan sel stem mesenkima (WJ-MSC) yang diperoleh daripada Jeli Wharton kurang mendapat perhatian. Kajian semasa ini mewakili percubaan klinikal Fasa I bagi label terbuka, reka bentuk lengan tunggal dalam konteks ini. Matlamat utamanya adalah untuk menilai keselamatan dan keberkesanan mentadbir sel stem mesenkima yang diperoleh daripada Jeli Wharton melalui suntikan intra-artikul untuk pesakit yang didiagnosis dengan osteoartritis lutut. Sepanjang enam bulan, kajian ini melihat peningkatan keseluruhan yang ketara secara statistik dalam pembentangan klinikal berbanding garis dasar. Peningkatan ini dimanifestasikan sebagai pengurangan penggunaan analgesik, pengurangan skor Skala Analog Visual (VAS) (19.5 hingga 18.7 mm, p = .00) dan skor penilaian fungsian yang ditambah, termasuk Skor IKDC (ditingkatkan daripada 62.2 kepada 100, p = .00), subskala Simptom KOOS dan Kekakuan (dinaikkan daripada 76.8% kepada 10.6%, p = .00) serta subskala Sakit KOOS (dinaik taraf daripada 74.4% kepada 10.1%, p = .00). Kajian ini melaporkan tiada kesan buruk yang ketara semasa tempoh pemerhatian. Walau bagaimanapun, selepas penilaian radiografi, tiada perubahan ketara diperhatikan dari sudut kecacatan (p = 0.957) atau medial (p = 0.871) dan sisi (p = 0.520) kelebaran petak ruang sendi. Untuk penjelasan lebih lanjut tentang keberkesanan perbandingan rawatan ini, adalah bijak mempertimbangkan percubaan terkawal rawak dan membandingkannya dengan rejimen asid hialuronik konvensional yang menyumbang kepada lebih pemahaman tentang potensi terapeutiknya.

Kata kunci: Jeli Wharton; lutut; osteoartritis; sel stem mesenkima; suntikan perkutaneus

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