Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age30-69
SponsorUniversity of Southern Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Adipose derived stem cell injection
Biological/VaccineA 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.
Placebo
Biological/VaccineStandard care
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Single injectionPlacebo comparator 1 intervention
Group B: Triple injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Oxford Shoulder Score (OSS)
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 12 monthsSecondary outcomes
1
Change in the Oxford Shoulder Score (OSS) at 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 3 months2
Change in the Oxford Shoulder Score (OSS) at 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 6 months3
Change in Quality of Life at 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 3 months4
Change in Quality of Life at 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 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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