Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

Обзор

The goal of this clinical trial is to learn whether a one-time injection of a person's own concentrated fat (micro-fragmented adipose tissue, or MFAT) can reduce pain and improve function in adults (ages 18-80) with chronic tendinopathy - tendon pain lasting more than 3 months (for example, in the shoulder, elbow, hip, knee, or Achilles) - that has not improved with usual treatments such as physical therapy, cortisone shots, or platelet-rich plasma. The main questions it aims to answer are: * Does injecting a person's own concentrated fat into a painful tendon reduce tendon pain? * Does it improve how well the tendon works, how long does any improvement last, and is the procedure safe? This is a single-group study, so there is no separate comparison group; each participant's pain, function, and ultrasound results after treatment are compared with their own measurements taken before treatment. Participants will: * Have a one-time procedure in which a small amount of fat is removed from the abdomen by liposuction (under local numbing), concentrated, and injected into the painful tendon using ultrasound guidance. * Complete short pain and function questionnaires and have ultrasound imaging of the tendon at study visits. * Be followed for about 12 months, with a phone or video check-in 3-7 days after the procedure, a 2-week skin check of the fat-removal site, and visits at 6 weeks, 3 months, 6 months, and 12 months.

Вмешательства

• Процедура Micro-Fragmented Adipose Tissue (MFAT) injection
  Autologous microfragmented adipose tissue (MFAT), i.e., mechanically concentrated autologous lipoaspirate, prepared and delivered in a single, same-day, point-of-care procedure. Under local anesthesia, 5-15 cc of subcutaneous abdominal fat is harvested by small-volume manual liposuction. The lipoaspirate is sterilely rinsed and concentrated by manual rolling on a non-adherent (Telfa) dressing; no enzymatic (collagenase) digestion, cell isolation, culture, or expansion is performed (minimal manip

Первичные конечные точки

• Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months [Срок оценки: Baseline (pre-procedure) and Month 6]

Вторичные конечные точки (12)

• Change From Baseline in Patient-Reported Pain (NRS) at Week 6 [Срок оценки: Baseline, Week 6]
• Change From Baseline in Patient-Reported Pain (NRS) at Month 3 [Срок оценки: Baseline, Month 3]
• Change From Baseline in Patient-Reported Pain (NRS) at Month 12 [Срок оценки: Baseline, Month 12]
• Mean Change From Baseline in LEFS at Week 6 [Срок оценки: Baseline - Week 6]
• Mean Change From Baseline in LEFS at Month 3 [Срок оценки: Baseline - Month 3]
• Mean Change From Baseline in LEFS at Month 6 [Срок оценки: Baseline - Month 6]
• Mean Change From Baseline in LEFS at Month 12 [Срок оценки: Baseline - Month 12]
• Mean Change From Baseline in HOOS Pain Subscale at Week 6 [Срок оценки: Baseline - Week 6]
• Mean Change From Baseline in HOOS Pain Subscale at Month 3 [Срок оценки: Baseline - Month 3]
• Mean Change From Baseline in HOOS Pain Subscale at Month 6 [Срок оценки: Baseline - Month 6]
• Mean Change From Baseline in HOOS Pain Subscale at Month 12 [Срок оценки: Baseline - Month 12]
• Mean Change From Baseline in HOOS Symptoms Subscale at Week 6 [Срок оценки: Baseline - Week 6]

Критерии участия

Критерии включения

• Age 18-80 years.
• Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar).
• Confirmed tendon pathology: pain at the tendon site for > 3 months AND pathology confirmed on ultrasound.
• Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks.
• Able to provide informed consent and complete questionnaires in English.

Критерии исключения

• Full-thickness tendon tear.
• Prior surgery at the target tendon site.
• Injection or other intervention at the target tendon site within the prior 6 months.
• Pregnancy or breastfeeding.
• Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe.
• Moderate-to-high-grade arthritis in the adjacent joint.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Department of Rehabilitation Medicine WCMC — New York

Публикации

• Fick B, Stover DW, Chimenti RL, Hall MM. The Safety of Ultrasound Guided Tenotomy and Debridement for Upper and Lower Extremity Tendinopathies: A Retrospective Study. Iowa Orthop J. 2021 Dec;41(2):82-90. PMID 34924874
• Aljerian A, Abi-Rafeh J, Hemmerling T, Gilardino MS. Complications of Aesthetic Liposuction Performed in Isolation: A Systematic Literature Review and Meta-Analysis. Plast Surg (Oakv). 2024 Feb;32(1):19-32. doi: 10.1177/22925503221078693. Epub 2022 Feb 21. PMID 38433796
• Jo CH, Chai JW, Jeong EC, Oh S, Kim PS, Yoon JY, Yoon KS. Intratendinous Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A First-In-Human Trial. Stem Cells. 2018 Sep;36(9):1441-1450. doi: 10.1002/stem.2855. Epub 2018 Jul 16. PMID 29790618
• Strong AL, Rubin JP, Kozlow JH, Cederna PS. Fat Grafting for the Treatment of Scleroderma. Plast Reconstr Surg. 2019 Dec;144(6):1498-1507. doi: 10.1097/PRS.0000000000006291. PMID 31764674
• Palumbo Piccionello A, Riccio V, Senesi L, Volta A, Pennasilico L, Botto R, Rossi G, Tambella AM, Galosi L, Marini C, Vullo C, Gigante A, Zavan B, De Francesco F, Riccio M. Adipose micro-grafts enhance tendinopathy healing in ovine model: An in vivo experimental perspective study. Stem Cells Transl Med. 2021 Nov;10(11):1544-1560. doi: 10.1002/sctm.20-0496. Epub 2021 Aug 16. PMID 34398527
• Oshita T, Tobita M, Tajima S, Mizuno H. Adipose-Derived Stem Cells Improve Collagenase-Induced Tendinopathy in a Rat Model. Am J Sports Med. 2016 Aug;44(8):1983-9. doi: 10.1177/0363546516640750. Epub 2016 Apr 11. PMID 27159294
• Nourissat G, Berenbaum F, Duprez D. Tendon injury: from biology to tendon repair. Nat Rev Rheumatol. 2015 Apr;11(4):223-33. doi: 10.1038/nrrheum.2015.26. Epub 2015 Mar 3. PMID 25734975
• Hopkins C, Fu SC, Chua E, Hu X, Rolf C, Mattila VM, Qin L, Yung PS, Chan KM. Critical review on the socio-economic impact of tendinopathy. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2016 Apr 22;4:9-20. doi: 10.1016/j.asmart.2016.01.002. eCollection 2016 Apr. PMID 29264258

Идентификаторы

NCT: NCT07748793 · 26-06030341 · 1621156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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