Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis

Summary

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.

Timeline

Start

2024-10-01

Primary completion

2028-10-01

Completion

2029-10-01

Publications

• Results Cisternas MG, Murphy L, Sacks JJ, Solomon DH, Pasta DJ, Helmick CG. Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey. Arthritis Care Res (Hoboken). 2016 May;68(5):574-80. doi: 10.1002/acr.22721.
• Results Van Manen MD, Nace J, Mont MA. Management of primary knee osteoarthritis and indications for total knee arthroplasty for general practitioners. J Am Osteopath Assoc. 2012 Nov;112(11):709-15.
• Results Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958.
• Results Gupta A, Potty ASR, Ganta D, Mistovich RJ, Penna S, Cady C, Potty AG. Streamlining the KOOS Activities of Daily Living Subscale Using Machine Learning. Orthop J Sports Med. 2020 Mar 24;8(3):2325967120910447. doi: 10.1177/2325967120910447. eCollection 2020 Mar.
• Results Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055/s-0039-1696672. Epub 2019 Sep 18.
• Results Hoorntje A, Witjes S, Koenraadt KLM, Aarts R, Weert T, van Geenen RCI. More Severe Preoperative Kellgren-Lawrence Grades of Knee Osteoarthritis were Partially Associated with Better Postoperative Patient-Reported Outcomes in TKA Patients. J Knee Surg. 2019 Mar;32(3):211-217. doi: 10.1055/s-0038-1635114. Epub 2018 Feb 28.
• Results Kahn TL, Soheili A, Schwarzkopf R. Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. Geriatr Orthop Surg Rehabil. 2013 Dec;4(4):117-26. doi: 10.1177/2151458514520634.
• Results Eyichukwu GO. Non-Steroidal anti inflammatory drugs usage in orthopaedics and trauma practice. A guide and review. Niger J Med. 2010 Oct-Dec;19(4):374-81. doi: 10.4314/njm.v19i4.61959.
• Results Yasir M, Goyal A, Sonthalia S. Corticosteroid Adverse Effects. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531462/
• Results Gupta A, Woods MD, Illingworth KD, Niemeier R, Schafer I, Cady C, Filip P, El-Amin SF 3rd. Single walled carbon nanotube composites for bone tissue engineering. J Orthop Res. 2013 Sep;31(9):1374-81. doi: 10.1002/jor.22379. Epub 2013 Apr 29.
• Results Lamplot JD, Rodeo SA, Brophy RH. A Practical Guide for the Current Use of Biologic Therapies in Sports Medicine. Am J Sports Med. 2020 Feb;48(2):488-503. doi: 10.1177/0363546519836090. Epub 2019 Apr 30.
• Results Rodriguez HC, Gupta M, Cavazos-Escobar E, El-Amin SF 3rd, Gupta A. Umbilical cord: an allogenic tissue for potential treatment of COVID-19. Hum Cell. 2021 Jan;34(1):1-13. doi: 10.1007/s13577-020-00444-5. Epub 2020 Oct 9.
• Results Gupta A, Cady C, Fauser AM, Rodriguez HC, Mistovich RJ, Potty AGR, Maffulli N. Cell-free Stem Cell-Derived Extract Formulation for Regenerative Medicine Applications. Int J Mol Sci. 2020 Dec 9;21(24):9364. doi: 10.3390/ijms21249364.
• Results Main BJ, Maffulli N, Valk JA, Rodriguez HC, Gupta M, El-Amin SF 3rd, Gupta A. Umbilical Cord-Derived Wharton's Jelly for Regenerative Medicine Applications: A Systematic Review. Pharmaceuticals (Basel). 2021 Oct 27;14(11):1090. doi: 10.3390/ph14111090.
• Results Gupta A, El-Amin SF 3rd, Levy HJ, Sze-Tu R, Ibim SE, Maffulli N. Umbilical cord-derived Wharton's jelly for regenerative medicine applications. J Orthop Surg Res. 2020 Feb 13;15(1):49. doi: 10.1186/s13018-020-1553-7.
• Results Dernek B, Duymus TM, Koseoglu PK, Aydin T, Kesiktas FN, Aksoy C, Mutlu S. Efficacy of single-dose hyaluronic acid products with two different structures in patients with early-stage knee osteoarthritis. J Phys Ther Sci. 2016 Nov;28(11):3036-3040. doi: 10.1589/jpts.28.3036. Epub 2016 Nov 29.

Drugs

Indications