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

Официальное название

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

Обзор

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.

Подробное описание

This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. 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.

As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.

Вмешательства

• Биопрепарат Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
  Direct injection of biologic into the knee joint.

Первичные конечные точки

• C Reactive Protein [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Erythrocyte Sedimentation Rate [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Alanine Transaminase [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Aspartate Transaminase [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Alkaline Phosphatase [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Albumin [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Creatinine [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]
• Blood Urea Nitrogen [Срок оценки: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year]

Вторичные конечные точки (3)

• 36-Item Short Form Survey (SF-36) [Срок оценки: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• Numerical Pain Rating Scale (NPRS) [Срок оценки: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year]
• Knee Injury and Osteoarthritis Outcome Score [Срок оценки: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year]

Критерии участия

Критерии включения

• Be over age 30
• Diagnosed with Grade II or III OA on the KL scale (in one knee).
• Body Mass Index (BMI) <50Kg/m2
• Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
• Female patients must be abstinent, surgically sterilized or postmenopausal
• Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
• Be willing and capable of giving written informed consent to participate in English.
• Be willing and capable of complying with study-related requirements, procedures and visits in English.

Критерии исключения

• Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
• Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
• Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
• Have had surgery on the index knee with the past 6 months.
• Had a traumatic injury to the index knee with the past 3 months.
• Planned elective surgery during the course of the study.
• A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
• Be on immunosuppressive medications.
• Have a diagnosis of carcinoma with the past 2 years.
• Have a knee infection or have used antibiotics for knee infection within the past 3 months.
• Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
• Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
• Contraindications to radiographic or MRI imaging.
• Serious neurological, psychological or psychiatric disorders.
• Injury or disability claims under current litigation or pending or approved workers compensation claims.
• Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• R3 Anti Aging Scottsdale — Scottsdale
• R3 Anti Aging Beverly Hills — Beverly Hills
• Optimal Medical Group — Fresno
• Scheer Medical Wellness — New York
• Dr. Duc (Steve) Le, MD — Cleveland

Публикации

• 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. PMID 26315529
• 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. PMID 23139341
• 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. PMID 22298051
• 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. PMID 32270015
• 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. PMID 31533151
• 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. PMID 29490401
• 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. PMID 24600532
• 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. PMID 21526623

Идентификаторы

NCT: NCT06608134 · R3-WJI-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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