Allogenic Human Umbilical Cord Derived Mesenchymal Stem Cells for Managing Knee Osteoarthritis in Human – A Clinical Trial

Abstract

Introduction: Human Mesenchymal Stem Cell has been scientifically accepted as a method of managing Osteoarthritis in the Human knee. They can be derived from Autologous Bone Marrow, Adipose Tissue, and less commonly Synovial Cells. However, Allogenic Human Umbilical Cord derived Mesenchymal Stem Cells has recently generated interest because harvesting it is noninvasive, availability easy, the cells relatively younger, have insignificant antigenic markers. A Clinical Trial of Allogeneic Intraarticular Human Umbilical Cord derived Mesenchymal Stem Cells was conducted to assess their efficacy in Osteo Arthritis Human Knees. Material and Method: The clinical trials were conducted from my clinic at 72 Tagore Town, Allahabad, UP, India from December 2018 to the third week of March 2021. The period of study was between December 2018 to April 2021. FIRST COVID Lockdown in this city was from 22nd of March 2020 to September 2020. The second Lockdown was from April 2021 to May 2021. Nine human subjects were selected initially for this clinical trial, but three were lost to follow-up. So 6 human subjects with bilateral knee Osteoarthritis (12 knees with OA) were studied in this clinical trial. The severity of the Knee Osteoarthritis was grade 2 to 3 of KL Score. After patient selection, Pre-Intra-Articular Injection, a Clinical Examination -General and local Knee Examination was done. Pre-determined functional outcome assessments using KOOS (Knee Injury and Osteoarthritis Scale) Outcome score, validated in Hindi, VAS (Visual Analogue Scale) Score, Kellgren Lawrence Score (KL Score), and Basal Metabolic Index recorded. After an Informed consent, each Knee was injected One Intraarticular Injection of Allogeneic Human umbilical Cord derived Mesenchymal Stem Cell (50x10^6). Cells were provided courtesy MEDITEKFUTURO, for this Clinical Trial. Six subjects with 12 knees were in this clinical trial. The follow-up after the Intra Articular Injection was at 15 ± 3 months and 24 ± 4 months. The first follow-up at 15 ± 3 months was during the first Covid Lockdown, done digitally by remote means, (The First Covid Lockdown in This District of Allahabad, State of Uttar Pradesh, India was from 22nd March 2020 to September 2020). The Lockdown was opened from October 2020 to April 2021. During this window, the second follow up 24 ± 4 months, was done clinically. (The second COVID lockdown was restarted from the end of April to 31st 2021 to the end of May 2021, in this City). The follow up post-injection results at 15 ± 3months and at 24 ± 4 months, recorded importantly for adverse reaction as per WHO guidelines (using CTCAE version 3 of NCI Common Terminology Criteria for Adverse Events, functional parameters did preoperatively were serially recorded at the two follow up period mentioned, and analyzed. The correlation with age and BMI was also analyzed. Results: • Allogenic Human Umbilical Cord derived Mesenchymal Stem Cells used as Intra articular Knee injections were found effective for managing Human Knee Osteoarthritis. • No local or generalized complications were observed by its use. • Knee function as assessed by KOOS Scale and VAS scale improved. • The Improvement continued till the end of the study. • The Clinical Outcomes continued with increasing age and BMI. Till the period of this Clinical trial. • The clinical trial during 15 ± 3months was done during the COVID lockdown using digital means of the functional KOOS and Vas scoring, which was done out of compulsion. • A larger multicenter trial for a longer time frame, of this Clinical Trial would be more statistically significant.