NCT Number: NCT07592936
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.
Trial opening soon.
Get Notified30 year–69 year
All sexes
Interventional
Phase 1 / Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard care
Time frame: Baseline and 12 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 3 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 6 months
The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst).
Time frame: Baseline and 3 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 6 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 12 months
Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health.
Time frame: Baseline and 3 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 6 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 12 months
Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments.
Time frame: Baseline and 6 months
Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy
Time frame: Baseline and 12 months
Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy
Time frame: Baseline and 6 months
Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy
Time frame: Baseline and 12 months
Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy
Time frame: Baseline and 3 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 6 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 12 months
Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient
Time frame: Baseline and 6 months
Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading
Time frame: Baseline and 12 months
Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading
Contact information is provided by the study sponsor or research team.
University of Southern Denmark
Other
Effects and Benefits of Repeated Injections of Adipose-derived Stem Cells on Shoulder Function in Rotator Cuff Tears: A Randomized Controlled Study
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