Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears

Официальное название

Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study

Обзор

The aim of the project is to investigate whether repeated implantations of micro-fragmented adipose tissue (MFAT), into the shoulder muscle can improve the outcome of standard surgical treatment for rotator cuff tears (RCT). The investigators hypothesize that combining surgery with repeated implantations of micro-fragmented adipose tissue (MFAT) into the muscle provides a more effective treatment for patients with rotator cuff tears compared to standard surgical treatment. The result would be better outcomes such as improved shoulder functioning and reduced pain.

Подробное описание

Treatment of RCTs with micro-fragmented adipose tissue is a minimal invasive procedure with the potential to shorten recovery, accelerate return to daily activity and work and improve functional outcomes compared to conventional surgery alone.

This study will provide evidence on whether three MFAT injections can augment conventional rotator cuff tear treatment. It will also assess the feasibility of implementing this treatment as part of standard care, given its potential for easy standardization. In addition to offering a novel therapeutic approach, the project will correlate functional outcomes with data from muscle biopsies, phenotypic composition of the implanted cells, imaging modalities, and patient reported outcomes. This study will generate critical new knowledge and serve as a cornerstone for the development of precision regenerative medicine in shoulder pathology. By elucidating patient-specific biological responses and therapeutic outcomes, the investigators aim to advance personalized treatment strategies for rotator cuff tears. Building on these findings, we aim to launch a clinical trial to further validate precision medicine as a standard therapeutic approach for patients suffering from rotator cuff tears.

Вмешательства

• Биопрепарат Adipose derived stem cell injection
  A total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. Adipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.
• Биопрепарат Placebo
  Standard care

Первичные конечные точки

• Change in the Oxford Shoulder Score (OSS) [Срок оценки: Baseline and 12 months]

Вторичные конечные точки (12)

• Change in the Oxford Shoulder Score (OSS) at 3 months [Срок оценки: Baseline and 3 months]
• Change in the Oxford Shoulder Score (OSS) at 6 months [Срок оценки: Baseline and 6 months]
• Change in Quality of Life at 3 months [Срок оценки: Baseline and 3 months]
• Change in Quality of Life at 6 months [Срок оценки: Baseline and 6 months]
• Change in Quality of Life at 12 months [Срок оценки: Baseline and 12 months]
• Change in Radiological healing at 3 months [Срок оценки: Baseline and 3 months]
• Change in Radiological healing at 6 months [Срок оценки: Baseline and 6 months]
• Change in Radiological healing at 12 months [Срок оценки: Baseline and 12 months]
• Change in infiltration with Goutallier at 6 months [Срок оценки: Baseline and 6 months]
• Change in infiltration with Goutallier at 12 months [Срок оценки: Baseline and 12 months]
• Change in infiltration with Fuchs at 6 months [Срок оценки: Baseline and 6 months]
• Change in infiltration with Fuchs at 12 months [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

• Clinical signs and symptoms compatible with a traumatic RCT
• MR verified supraspinatus tear
• Reparable lesion with tendon retraction < 2 cm.
• Fatty infiltration level 0-2 according to Fuchs or out of 5 based on Goutalliers classification
• No history of inflammatory disease
• Negative infectious disease marker tests Signed consent to the study

Критерии исключения

• Former surgery in the affected shoulder
• Signs of infection
• Immunosuppression (due to clinical condition or medical therapy)
• Any malignancy within 5 years prior to screening
• Previous radiotherapy to the shoulder
• BMI under 18
• BMI above 35
• Allergy to antibiotics such as penicillin
• Coagulopathy

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07592936 · SHS-Orto-2026-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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