The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

Официальное название

A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

Обзор

To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

Подробное описание

The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

A total of 240 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.

Вмешательства

• Биопрепарат Autologous cell therapy
  Biologic material is harvested from the participant and re-injected into an osteoarthritic joint

Первичные конечные точки

• Changes from baseline through to end of study for the Visual Analogue Scale (VAS). [Срок оценки: The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).]
• Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2) [Срок оценки: The SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).]

Вторичные конечные точки (3)

• Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) from baseline visit through to end of study. [Срок оценки: The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).]
• Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study. [Срок оценки: The SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).]
• Flow cytometry [Срок оценки: Visit 2 (Week 1) Samples are collected at visit 2 (week 1) and sent away for analysis by a university. The results will be received from the university prior to end for overall data analysis.]

Критерии участия

Критерии включения

• Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
• Male or female at least 19 years of age at the time of providing written informed consent.
• Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren \& Lawrence Grades 1-3 are accepted for participation.

Критерии исключения

• BMI > 35
• Arthroscopic surgery to the treatment joint within 12 months
• Cortisone or HA injection within the last 3 months prior to stem cell injection
• Inability to hold antiplatelet therapy according to treating provider prior to procedure
• Kellgren \& Lawrence Grade 4 Osteoarthritis
• Participants with a platelet count less than 100 x 109
• Participants with a Hemoglobin less than 100 g/L
• Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
• Participants with an active Cancer diagnosis.
• Participants with autoimmune disorders including rheumatoid arthritis and lupus.
• Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
• Participants with allergies to lidocaine, heparin, or epinephrine.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Pagdin Health — Kelowna

Идентификаторы

NCT: NCT03984461 · OASC2015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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