Ashim Gupta1,2,3,4, Nicola Maffulli5,6,7,8, Hugo C Rodriguez2,3,9,10, Eric W Carson11, Randa A Bascharon12, Kristin Delfino13, Howard J Levy1,14, Saadiq F El-Amin15,16. 1. BioIntegrate, Lawrenceville, GA, USA. 2. Future Biologics, Lawrenceville, GA, USA. 3. South Texas Orthopaedic Research Institute, Laredo, TX, USA. 4. Veterans in Pain, Los Angeles, CA, USA. 5. Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Fisciano, Italy. 6. San Giovanni di Dio e Ruggi D'Aragona Hospital "Clinica Orthopedica" Department, Hospital of Salerno, Salerno, Italy. 7. Barts and the London School of Medicine and Dentistry, Centre for Sports and Exercise Medicine, Queen Mary University of London, London, UK. 8. School of Pharmacy and Bioengineering, Keele University School of Medicine, Stoke-on-Trent, UK. 9. Future Physicians of South Texas, San Antonio, TX, USA. 10. University of the Incarnate Word, School of Osteopathic Medicine, San Antonio, TX, USA. 11. Department of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, USA. 12. Orthopedic & Sports Medicine Institute of Las Vegas, Las Vegas, NV, USA. 13. Southern Illinois University, School of Medicine, Springfield, IL, USA. 14. Department of Orthopaedic Surgery, Lenox Hill Hospital, Northwell Health, New York, NY, USA. 15. BioIntegrate, Lawrenceville, GA, USA. dr.saadiqelamin@gmail.com. 16. El-Amin Orthopaedic and Sports Medicine Institute, 2505 Newpoint Pkwy, Suite - 100, Lawrenceville, GA, 30043, USA. dr.saadiqelamin@gmail.com.
Abstract
BACKGROUND: Osteoarthritis (OA) is the most common joint disorder in the United States of America (USA) with a fast-rising prevalence. Current treatment modalities are limited, and total knee replacement surgeries have shown disadvantages, especially for grade II/III OA. The interest in the use of biologics, including umbilical cord (UC)-derived Wharton's jelly (WJ), has grown in recent years. The results from a preliminary study demonstrated the presence of essential components of regenerative medicine, namely growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles, including exosomes, in WJ. The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms. METHODS: A randomized, controlled, single-blind, multi-center, prospective study will be conducted in which the safety and efficacy of intra-articular administration of UC-derived WJ are compared to HA (control) and saline (placebo control) in patients suffering from grade II/III knee OA. A total of 168 participants with grade II or III knee OA on the KL scale will be recruited across 53 sites in the USA with 56 participants in each arm and followed for 1 year post-injection. Patient satisfaction, Numeric Pain Rating Scale, Knee Injury and Osteoarthritis Outcome Score, 36-Item Short Form Survey (SF-36), and 7-point Likert Scale will be used to assess the participants. Physical exams, X-rays, and MRI with Magnetic Resonance Observation of Cartilage Repair Tissue score will be used to assess improvement in associated anatomy. DISCUSSION: The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis. The results of this study will also add to the treatment options available for grade II/III OA as well as help facilitate the development of a more focused treatment strategy for patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04711304 . Registered on January 15, 2021.
RCT Entities:
BACKGROUND:Osteoarthritis (OA) is the most common joint disorder in the United States of America (USA) with a fast-rising prevalence. Current treatment modalities are limited, and total knee replacement surgeries have shown disadvantages, especially for grade II/III OA. The interest in the use of biologics, including umbilical cord (UC)-derived Wharton's jelly (WJ), has grown in recent years. The results from a preliminary study demonstrated the presence of essential components of regenerative medicine, namely growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles, including exosomes, in WJ. The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms. METHODS: A randomized, controlled, single-blind, multi-center, prospective study will be conducted in which the safety and efficacy of intra-articular administration of UC-derived WJ are compared to HA (control) and saline (placebo control) in patients suffering from grade II/III knee OA. A total of 168 participants with grade II or III knee OA on the KL scale will be recruited across 53 sites in the USA with 56 participants in each arm and followed for 1 year post-injection. Patient satisfaction, Numeric Pain Rating Scale, Knee Injury and Osteoarthritis Outcome Score, 36-Item Short Form Survey (SF-36), and 7-point Likert Scale will be used to assess the participants. Physical exams, X-rays, and MRI with Magnetic Resonance Observation of Cartilage Repair Tissue score will be used to assess improvement in associated anatomy. DISCUSSION: The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis. The results of this study will also add to the treatment options available for grade II/III OA as well as help facilitate the development of a more focused treatment strategy for patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04711304 . Registered on January 15, 2021.
Authors: Miriam G Cisternas; Louise Murphy; Jeffrey J Sacks; Daniel H Solomon; David J Pasta; Charles G Helmick Journal: Arthritis Care Res (Hoboken) Date: 2016-05 Impact factor: 4.794
Authors: Ashim Gupta; Mia D Woods; Kenneth David Illingworth; Ryan Niemeier; Isaac Schafer; Craig Cady; Peter Filip; Saadiq F El-Amin Journal: J Orthop Res Date: 2013-04-29 Impact factor: 3.494
Authors: Ashim Gupta; Benjamin J Main; Brittany L Taylor; Manu Gupta; Craig A Whitworth; Craig Cady; Joseph W Freeman; Saadiq F El-Amin Journal: J Biomed Mater Res A Date: 2014-01-28 Impact factor: 4.396
Authors: Elena Losina; Thomas S Thornhill; Benjamin N Rome; John Wright; Jeffrey N Katz Journal: J Bone Joint Surg Am Date: 2012-02-01 Impact factor: 5.284
Authors: Alexander Hoorntje; Suzanne Witjes; Koen L M Koenraadt; Ruud Aarts; Thomas de Weert; Rutger C I van Geenen Journal: J Knee Surg Date: 2018-02-28 Impact factor: 2.757
Authors: Adarsh Aratikatla; Nicola Maffulli; Hugo C Rodriguez; Manu Gupta; Anish G Potty; Saadiq F El-Amin; Ashim Gupta Journal: J Orthop Surg Res Date: 2022-06-11 Impact factor: 2.677